Real World Use of Pegylated Erythropoietin in CKD Anemia: An Indian Modified Delphi Consensus

Real World Use of Pegylated Erythropoietin in CKD Anemia: An Indian Modified Delphi Consensus | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Real World Use of Pegylated Erythropoietin in CKD Anemia: An Indian Modified Delphi Consensus Vijay Kher, Jatin Kothari, Jitendra Kumar, Sanjay Srinivas, Prashant Kedlaya, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8706096/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Anemia is a common complication in chronic kidney disease (CKD) and is associated with adverse outcomes particularly in the advanced stage. Iron therapy and Erythropoesis stimulating agents (ESAs) form the cornerstone of its management. Among ESAs, there are various options available for usage, however each one differs in its structure and frequency of administration. Pegylated erythropoietin is having the longest half life, and is available for usage in renal anemia in India for long time but somewhat is less utilized in therapy. This consensus was done to generate expert consensus from practising Nephrologists from India regarding pegylated erythropoietin utility in CKD induced anemia Methods Using a modified Delphi methodology, an expert panel underwent three rounds of survey and came up with the expert consensus. Responses were recorded using 5- point Likert scale. Results A total of 35 consensus statements were generated, 12/35 (100%) had unanimous agreement, 9/35 had > 90% agreement and rest of them were above the predefined threshold of > 75%. Conclusions Pegylated erythropoietin, being the longest acting ESA has certain advantages like longer half life, lesser Hb fluctuations and lesser pricks, has shown to be non inferior to other ESAs in various phase 3 and real world studies. The consensus statement in this study will guide the nephrologists regarding usage of pegylated erythropoietin in renal anemia and its placement in the therapy. Chronic Kidney Disease Anemia Pegylated erythropoietin Figures Figure 1 Figure 2 Background Chronic Kidney Disease (CKD) remains one of the global concern of the health sector and has long been identified as an independent risk factor for the development of end-stage renal disease, cardiovascular morbidity and mortality [1]. Anemia is one of the frequent manifestations of CKD and largely results from inadequate erythropoietin production, iron deficiency and inflammation, therefore associated with reduced exercise capacity, impaired quality of life, faster CKD progression, higher hospitalization and death rates [2]. In India and the Asian region, the prevalence of renal anemia remains particularly high with reported rate of above 40-70%, and steadily increases with stages of severity of CKD [3, 4]. Erythropoiesis-Stimulating Agents (ESAs) remain the cornerstone of pharmacotherapy for CKD-induced anemia for more than two decades after correcting underlying reversible causes like iron deficiency anemia and inflammation. [5]. Recent Kidney Disease: Improving Global Outcomes (KDIGO) 2026 anemia guidelines, as well as Consensus guidelines published by Indian Society of Nephrology, recommend judicious use of ESAs to keep hemoglobin levels within a ‘conservative’ target range, taking into account both symptomatic relief and potential risks of excess hemoglobin levels, as well as excessive doses of ESAs. [4, 6]. Conventional ESAs, such as darbepoetin alpha and epoetin alfa, must be administered on a weekly or every two-week basis, are prone to hemoglobin cycling, demand a significant amount of clinic time, and place a significant treatment load on both CKD patients and dialysis center staff. [1, 7, 8]. Methoxy polyethylene glycol epoetin beta (pegylated erythropoietin; PegEPO, continuous erythropoietin receptor activator) is a 'third-generation' erythropoiesis-stimulating agent formed by covalent attachment of a methoxy polyethylene glycol chain to the epoetin beta molecule, thereby enormously increasing its half life and the duration of erythropoietin receptor activation. [1] Its very long terminal half life of about 130 hrs for dialysis and nondialysis CKD patients given either subcutaneously and/or intravenously allows its once-monthly maintenance doses to provide more stable levels of hemoglobin. [9] Phase III and post-marketing experience has proved PegEPO to be at least as effective and well-tolerated as conventional erythropoiesis-stimulating agents for both correcting and maintaining renal anemia. Additionally, it also offers longer-dosing intervals and possibly lowers healthcare system load [4]. Real world studies conducted on Indian and Asian CKD patients have indicated that effective dose schedules of PegEPO are capable of improving hemoglobin levels. [10,11] In a multi-center observational study conducted in Indian patients (HEMEPEG), significant increases in hemoglobin levels were achieved with weekly or 10-day treatment with 30µg doses of PegEPO, and about 50% of patients achieved hemoglobin levels of 10-12g/dL. [11] One of the important causes for anemia in patients with chronic kidney disease, particularly in dialysis, is erythropoietin resistance. In patients undergoing treatment with erythropoietin, 10% become resistant and require high doses of the drug. [12] Higher doses of ESAs are associated with increased morbidity and mortality. [13] Treatment with PegEPO in patients with chronic kidney disease resulted in a hemoglobin increase comparable to darbepoetin, while requiring a lower therapeutic dose [14]. Erypeg® (pegylated erythropoietin) is a biosimilar of Mircera® (Innovator pegylated erythropoetin) developed by Intas Pharmaceuticals (India). Its efficacy and safety have been demonstrated in a bioequivalence study involving 126 non-dialysis chronic kidney disease patients [15]. Erypeg® received approval from the Drug Controller General of India (DCGI) in 2016 for the treatment of renal anemia in both dialysis-dependent and non-dialysis-dependent patients, and provides a cost-effective therapeutic option for Indian patients in whom pegylated erythropoietin therapy is indicated. Despite these benefits, according to Dialysis Outcomes and Practice Patterns Study (DOPPS) study, the usage of PegEPO in CKD anemic patients is just 3-26% [16]. Therefore, this expert consensus was conducted to provide recommendations on usage of PegEPO, focussed to the Indian healthcare context so as to optimize the treatment of anemia in CKD and improve patient outcomes. Material and methods Development of the Delphi Panel Questionnaire For conducting the expert consensus, an expert panel was constituted comprising of 12 experienced clinicians, all of whom were well qualified nephrologists with each one having more than 15 years of clinical experience in the management of renal anemia. Their professional experience encompassed both hospital-based practice and individual center–based care. All panellists held clinical leadership positions at their respective institutions. A steering committee, comprising of three experienced nephrologists was constituted to guide the Delphi process, with additional support provided by other nephrologists to the steering committee. Data from relevant studies evaluating the dosing, efficacy, and safety of pegylated erythropoietin (PegEPO) were shared with the expert panel for review as part of the preparatory phase for the Delphi consensus development. Key topics requiring clinical expertise were identified, discussed, and finalized by the panel chair. These topics included patient selection, dosing strategies, iron management, switching from other erythropoiesis-stimulating agents (ESAs), target hemoglobin levels and monitoring, safety outcomes, and cost considerations. A pre-meeting reading material was distributed to all panel members to prepare for the meeting, based on these domains. This material mainly focused on data regarding PegEPO's utility in CKD anemia. Subsequently, an advisory board meeting was conducted prior to the Round 1 survey, during which survey-related topics were discussed in detail. Another in-person meeting was used to facilitate structured discussion and raise relevant issues for consideration, consistent with established Delphi methodology. Survey questions were finalized following consultation with the panel chair. Modified Delphi Panel Survey The Modified Delphi panel survey on the use of pegylated erythropoietin (PegEPO) in CKD-related anemia comprised two in-person meetings and three online survey rounds. The process flow chart is mentioned in Fig. 1 . Consensus for a statement was predefined as agreement by more than 75% of panelists (≥ 9 of 12), on a 5 point Likert scale. (1-Strongly Disagree, 2-Disagree, 3-Neutral, 4-Agree, 5-Strongly Agree). This was used in all three rounds of polling Round 1 consisted of 33 online survey questions and was conducted between September 21 and September 30, 2025. Responses were recorded using a Likert scale. Based on the analysis of Round 1 responses, Round 2 was conducted between November 15 and November 30, 2025, and included 21 close-ended online survey questions. This was followed by a second in-person meeting to discuss areas lacking consensus. Round 3 comprised 12 online survey questions. Responses were again obtained in a 5 point likert scale in all three surveys. Based on inputs provided by the advisors on Likert scale, a total of 31 statements were generated for Round 1 of the Delphi process. These statements were categorized by clinical setting and addressed key domains including patient selection, dosing and administration, iron management, switching from other erythropoiesis-stimulating agents (ESAs), hemoglobin targets and management, safety outcomes, and cost considerations. In Round 1, consensus was achieved for 10 of the 31 statements. Statements that did not reach consensus were reviewed, refined, and subsequently included in Round 2, which was conducted online. Round 2 comprised six modified statements derived from Round 1, all of which achieved consensus. Overall, consensus was achieved for 13 of 26 statements evaluated in Round 2. Following the two survey rounds, an in-person advisory board meeting was conducted in Dec’ 25 and topics which were not having consensus in two rounds were discussed. In round 3, 14 statements were subjected to live polling. Consensus was achieved for 12 of these statements. (Fig. 2 ) Results Final recommendation/statement Consensus* (%) Patient Selection Long acting ESA is the first choice as ESA for anemia management in non dialysis dependent (NDD) patients 83 De novo patients are more suitable for PegEPO therapy 75 Pegylated erythropoetin is suitable for switch patients from short acting ESAs 83 Pegylated erythropoetin can be considered the first-line ESA in CKD stage 5D patients 75 Patients who need ESA conversion from intravenous (IV) to subcutaneous (SC) are more suitable to PegEPO therapy 92 Pegylated erythropoetin is safe to use in elderly CKD patients without dose adjustments beyond standard recommendation 83 ESA hyporesponsive patients should be prescribed PegEPO as ESA therapy 83 Patients who frequently misses their ESA injections and have poor compliance can be shifted to PegEPO 100 PegEPO provides better haemoglobin (Hb) stabilization compared to short acting ESAs 92 Iron Management Ferritin > 200 ng/mL and Transferrin saturation (TSAT) > 20% should be ensured before initiating PegEPO 92 IV iron should be administered proactively in all Dialysis dependent patients to be initiated on PegEPO 92 Patients with stable iron stores (TSAT ≥ 25% and ferritin ≥ 200 ng/mL) are more likely to have predictable response to pegylated erythropoetin 100 Combining PegEPO with IV iron during the same visit improves patient compliance and outcomes 92 Switching from Other ESAs A once-monthly dosing frequency improves patient adherence and clinic workflow. 83 Longer dosing intervals with PegEPO reduce the risk of Hemoglobin variability associated adverse outcomes 83 Patients with Hb variability or requiring frequent dose changes on Darbepoetin/ short acting ESAs should be shifted to PegEPO 100 Patients with stabilized Hb on fortnightly ESA injections can be considered for safely switching to monthly PegEPO without compromising anemia control 100 PegEPO is able to maintain Hb levels when administered once every 2–4 weeks, subcutaneous or intravenous, in patients who were previously maintained on EPO alpha or Darbepoetin 100 Hb Targets & Monitoring Hemoglobin should be monitored every 2 weeks after initiation or dose adjustment with PegEPO 75 Monthly Hb monitoring is sufficient after dose stabilization 100 More frequent Hb monitoring (every 2 weeks) is required during the first two months after switching to PegEPO 83 Target Hb should be maintained between 10–12 g/dl in patients on PegEPO 100 Dose consideration The starting dose of PegEPO in denovo/ switch patients should be 50 mcg fortnightly 93 A loading dose of 100 mcg can be considered in patients having Hb < 9 g/dl 93 Fortnighly dosing is better than monthly dosing 93 Conversion ratios to PegEPO are well established and practical in real world settings 83 In Hemodialysis (HD) patients, PegEPO should be administered at the end of Dialysis session 100 For patients not achieving the desired Hb level, shortening the dosing interval is preferable than changing the dose 100 In case of dose discrepancy on per kg body weight, the nearest upper mcg dose can be considered for administration 100 Safety, Outcomes, and Cost If cost is not a concern, Pegylated erythropoietin should be preferred over other ESAs considering its advantages like less frequency of administration, less Hb variability and stable rise in Hb 83 Pegylated EPO has a comparable safety profile to other ESAs 83 Pegylated EPO is cost effective compared to more frequently used thrice weekly ESA injections 75 Pegylated EPO is safe to use in elderly CKD population 100 PegEPO is safe in patients with previous minor ESA-related adverse events 100 Considering the local geographical and practical challenges, PegEPO seems to be a better option than other long and short acting ESAs in Indian healthcare settings 93 Consensus statements Patient selection Long acting ESA is the first choice as ESA in non dialysis dependent (NDD) patients De novo patients are more suitable for PegEPO therapy Pegylated EPO can be considered the first-line ESA in CKD stage 5D patients Pegylated EPO is suitable for switch patients from short acting ESAs Patients who need ESA conversion from IV to SC are more suitable to PegEPO therapy Pegylated EPO is safe to use in elderly CKD patients without dose adjustments beyond standard recommendation ESA hyporesponsive patients should be prescribed PegEPO as ESA therapy Patients who frequently miss their ESA injections and have poor compliance can be shifted to ESA therapy PegEPO provides better Hb stabilization compared to short acting ESAs The prevalence of anemia grows as the stage of CKD progresses from 40% in stage 3 to 70% in stage 5. [ 17 ]. Due to high inflammation and functional iron deficiency, symptoms of anemia are more severe in dialysis patients than non dialysis. Prevalence of anemia in stage 3a-5 CKD is 39.6% according to a study conducted by Minutolo et al. [ 18 ]. However, as per CKDoPPS study, 68% of NDD patients neither receive Iron nor ESA for their anemia management [ 19 ]. Furthermore, patients with stage 4 and stage 5 CKD appear to be undertreated, where only 24% and 32% of individuals receive any form of treatment respectively. [ 20 ]. Majority of NDD patients suffer from mild to moderate anemia [ 21 ]. A discrete choice experiment carried out with Non-Dialysis-Dependent CKD anemic patients found that those with anaemia regard the method and frequency of treatment administration as a significant factor. [ 22 ]. Longer acting ESAs administered weekly or fortnightly is a preferable choice compared to three times short acting ESA administration, particularly in non dialysis patients. Pegylated Erythropoetin has shown its efficacy in de novo patients in multiple clinical trials. In CORDATUS trial, the Hb response rate with monthly injection was 94.1%, which was significantly higher than the protocol-specified 60% and was comparable to Darbepoetin. It was also non inferior to Darbepoetin in Hb rise at 28 weeks. Safety profile was also similar in both the arms [ 23 ]. In ARCTOS trial, Hb response rates with Pegylated Erythropoetin was similar to Darbepoetin in de novo NDD patients. PegEPO injection once every 2 week was as effective as darbepoetin alfa once weekly for correcting anemia. [ 24 ] Pegylated erythropoietin has been tested in multiple trials when patients stable on other ESAs were switched to PegEPO therapy. In phase III STRIATA trial, efficacy and safety of intravenous PegEPO administered once every 2 weeks (Q2W) was evaluated for Hb maintenance following direct conversion from darbepoetin alfa (DA) [ 25 ]. The mean difference in the primary endpoint was clinically non inferior to DA and both the therapies were well tolerated. The MAXIMA and PROTOS studies evaluated the efficacy of PegEPO administered via intravenous and subcutaneous routes, respectively, in maintaining haemoglobin levels in haemodialysis patients previously treated with epoetin. [ 26 , 27 ]. In MAXIMA, 673 patients receiving intravenous epoetin once or three times weekly were randomised to continue epoetin or to switch to intravenous PegEPO administered every 2 or 4 weeks. Similarly, the PROTOS study randomised 572 patients receiving subcutaneous epoetin to continue epoetin or to receive subcutaneous PegEPO every 2 or 4 weeks. Both studies demonstrated that pegylated erythropoetin, administered once monthly, maintained haemoglobin concentrations within the target range with efficacy comparable to conventional epoetin therapy, supporting its effectiveness in the management of anaemia in chronic haemodialysis patients [ 26 , 27 ] In a real-world study, 127 dialysis-dependent patients receiving conventional erythropoiesis-stimulating agents were switched to a once-monthly pegylated erythropoietin regimen. Monthly administration of PegEPO maintained stable haemoglobin concentrations with an acceptable safety profile. A median monthly dose reduction was also observed, decreasing from 120 µg during the dose-titration period (DTP) to 100 µg during the efficacy evaluation period (EEP) [ 28 ]. In HD patients, vascular access allows the convenience for intravenous administration of ESAs. However, there are two choices in NDD i.e subcutaneous or intravenous. In non-haemodialysis patients, the subcutaneous route may be more convenient due to the absence of continuous intravenous access, ease of self-administration, lower dose requirements, fewer hospital visits, reduced dosing frequency, and overall lower treatment costs. [ 29 ]. Studies have also demonstrated that shifting the patients from IV to S.C injection results in significant cost benefit to the patients and total ESA dose reduction [ 29 ]. Since PegEPO provides the convenience of fortnightly or monthly administration with comparable efficacy and safety, it can be considered as a preferred choice over other existing ESAs. In a study conducted in a geriatric population (> 65 years) suffering from chronic anemia, ESA therapy was associated with increases in Hb and improvements in fatigue and quality of life (QOL) [ 30 ]. In a recent meta analysis, patients receiving higher doses of erythropoiesis-stimulating agents (75,000, 100,000, and 200,000 U/week) had progressively increased mortality risks, with hazard ratios of 1.85 (95% CI: 1.55–2.23), 1.89 (95% CI: 1.53–2.30), and 2.07 (95% CI: 1.46–2.95), respectively. [ 31 ]. Also, high dose of ESA independently predicted cardiovascular mortality and mortality from all causes (31). Recently published studies have shown that conversion from short half-life erythropoiesis-stimulating agents to once-monthly subcutaneous PegEPO in pre-dialysis CKD patients effectively maintained haemoglobin levels, with a significant reduction in dose requirements. [ 32 ]. In MINERVA study, conversion from shorter-acting erythropoiesis-stimulating agents to PegEPO at doses lower than those recommended effectively maintained target haemoglobin levels in both non-dialysis and haemodialysis CKD patients, particularly among those previously receiving higher ESA doses [ 33 ]. Therefore, in geriatric populations, switching to PegEPO might provide benefits in terms of dose reduction and reduced morbidity ESA hyporesponsiveness is commonly defined as the requirement for high ESA doses to maintain haemoglobin levels within the target range, or the failure to achieve target haemoglobin despite such dosing. Patient receiving epoetin, 450 U/kg per week, with Hb level of 100 g/L would have an ESA resistance index of 4.5 [ 34 ]. The prevalence varies from 5–20% in HD population [ 35 ]. There are many causes associated with ESA hyporesponsiveness, important ones being iron deficiency, inflammation, uremia, Chronic Kidney Disease Mineral Bone Disease (CKD- MBD), malnutrition, inadequate dialysis, marrow failure etc. [ 36 ]. ESA hyporesponsiveness has been associated with thrombotic events in dialysis patients. [ 34 ]. Since increasing the doses in ESA hyporesponsive patients increases the cardiovascular morbidity, the panel agreed to switch to PegEPO to observe the response before giving supramaximal doses of short acting ESAs. However, evaluating the Hb response after a time period of 2 months appears to be appropriate after initiating PegEPO therapy [ 37 ] It is seen that approximately 90% of hemodialysis patients experience significant fluctuations in Hb levels over time [ 38 ]. Greater fluctuations in hemoglobin levels during treatment with erythropoiesis-stimulating agents (ESAs) are associated with a higher risk of infections, thrombotic complications, and all-cause mortality in patients undergoing hemodialysis [ 36 ]. Studies have shown that Hb variability has been associated with mortality in ND patients and is independent of the absolute Hb level, change in Hb level over time, and ESA use. The increased hemoglobin variability observed in patients receiving ESAs is likely multifactorial, arising from factors such as the drug’s half-life and dosing practices, fluctuations in patient clinical status, and changes in iron availability. [ 39 ] ESA dosing/frequency and administration route (intravenous, subcutaneous) is an important factor contributing to haemoglobin variability in patients with CKD [ 40 ]. Some studies suggest that long-acting ESAs may reduce hemoglobin variability by allowing less frequent dosing and promoting more stable erythropoiesis; however, other reports show no significant difference, or even greater hemoglobin variability with certain agents [ 41 ]. However, long-acting agents are generally presumed to maintain more stable hemoglobin levels—due to fewer dose adjustments and less frequent injections than short or intermediate-acting agents. In clinical environments characterized by high provider workload and fewer reimbursement constraints on ESA use, long-acting ESAs may be favoured in these settings. Switch to different types of ESA (e.g., longer acting ESA for noncompliant patients with frequent missing of dialysis treatments) seems to be a fair option for reducing Hb excursions in certain patients. [ 40 ], rather than keep on increasing or decreasing the dosage of same ESA in the patient. Iron Management Ferritin >200 ng/mL and TSAT >20% should be ensured before initiating PegEPO IV iron should be administered proactively in all Dialysis Dependent patients initiated on PegEPO Patients with stable iron stores (TSAT ≥25% and ferritin ≥200 ng/mL) are more likely to have predictable response to PegEPO Combining PegEPO with IV iron during the same visit improves patient compliance and outcomes Iron deficiency is one of the most important causes of ESA hypo responsiveness. [ 35 ] Therefore, guidelines suggest checking the iron stores before initiating ESA therapy. [ 6 ] Iron deficiency can be either absolute or functional, therefore, correcting the body iron stores before increasing the ESA doses is a recommended step in anemia management in CKD. Various clinical studies have supported the proactive iron dose therapy over reactive one. In Proactive, High-Dose versus Reactive, Low-Dose Intravenous Iron Supplementation in Hemodialysis (PIVOTAL) trial, conducted in HD patients, a proactive strategy was superior to a reactive low-dose regimen and resulted in the use of lower overall doses of erythropoiesis-stimulating agents [ 42 ]. The median monthly dose of erythropoiesis-stimulating agent was 19.4% lower in patients receiving the high-dose regimen [ 42 ]. Additionally in this trial, high-dose regimen of intravenous iron administered proactively resulted in a significantly lower risk of death or major nonfatal cardiovascular events as compared with that observed with a reactive, low-dose regimen. [ 42 ] Sufficient iron availability is crucial for effective erythropoiesis, as both absolute and functional iron deficiency significantly contribute to ESA hyporesponsiveness and hemoglobin variability in populations with chronic kidney disease and those undergoing hemodialysis. [ 43 ] Clinical practice guidelines suggest that in hemodialysis patients, TSAT should be maintained above approximately 20–25% and ferritin levels should exceed 200 ng/mL to guarantee an adequate iron supply to the bone marrow, thereby optimizing the erythropoietic response to ESA therapy [ 44 ] These established thresholds are indicative of targets associated with enhanced hemoglobin responses and a decrease in the need for higher ESA dosing, while lower levels of TSAT or ferritin are linked to diminish iron availability and compromised erythropoietic responsiveness. Carelessness and insufficient disease-related information are frequently blamed for non-adherence in NDD patients [ 45 ]. The presence of a central venous catheter, the actual dialysis day, procedural discomfort, the most recent advice from medical professionals, and the frequency of counselling, on the other hand, have a significant impact on compliance among dialysis-dependent (DD) patients [ 46 ]. Perception of the importance of treatment adherence was missing in the patients in the study [ 46 ]. Considering all the factors discussed, healthcare professionals should individualize interventions according to patients’ specific risk profiles, with the goal of enhancing patients’ perception of the importance of treatment adherence, and combining both ESAs and Iron in a single session might improve adherence to ESA therapy. Additionally, Intravenous iron may also aid with overcoming ESA resistance that has been observed when an ESA has been used without concomitant IV iron [ 47 ]. Switching from Other ESAs A once-monthly dosing frequency improves patient adherence and clinic workflow. Longer dosing intervals with PegEPO reduce the risk of Hb variability–associated adverse outcomes Patients with Hb variability or requiring frequent dose changes on Darbepoetin/ short acting ESAs should be shifted to PegEPO Patients with stabilized Hb on fortnightly ESAs can be considered for safely switching to monthly PegEPO without compromising anemia control PegEPO is able to maintain Hb levels when administered once every 2-4 weeks SC or IV, in patients who were previously maintained on erythropoetin alpha or Darbepoetin Dosing frequency undoubtedly has a significant impact on patients' adherence. Reducing the frequency of dosing improved adherence to oral therapies, according to a meta-analysis [ 48 ]. Once-weekly dosing was linked to better patient adherence to therapy than once-daily dosing, according to another study that examined the relationship between intermittent dosing and adherence [ 49 ]. One way to increase the effectiveness of care is to use ESAs at longer dosage intervals. Once-monthly dosing reduces the amount of time needed to administer and monitor therapy and enables nephrology specialists to provide comprehensive renal care where the patient takes precedence over task-oriented procedures [ 50 ]. Changes in ESA dosage or clinical events are often linked to hemoglobin variability. Compared to short-acting EPO, long-acting ESA produced greater hemoglobin stability. (26) Research has indicated that a sharp increase in hemoglobin levels is linked to poorer cardiovascular outcomes. [ 51 , 52 ]. Within dosing intervals unique to each ESA class, the maximum efficacy of ESAs is attained [ 53 ]. Epoetin alfa's effectiveness decreases in hemodialysis patients receiving short-acting ESAs subcutaneously or intravenously when the dosage is lowered from three times weekly to once weekly, and it further declines when the interval is increased to every other week [ 7 ]. On the other hand, long-acting ESAs exhibit optimal efficacy at longer, agent-specific intervals: pegylated erythropoetin exhibits maximal efficacy with once-monthly (every four weeks) dosing, while darbepoetin alfa appears to be most effective when given every two weeks [ 54 ]. Differences in pharmacokinetic characteristics, especially drug half-life, must be carefully taken into account when transferring patients from short-acting to long-acting ESAs [ 55 ]. For example, conversion from thrice-weekly epoetin alfa to once-monthly PegEPO has been shown to substantially reduce injection frequency while maintaining hemoglobin concentrations within the recommended target range in patients with chronic kidney disease. Multiple studies have confirmed that patients on stable Darbepoetin weekly or Recombinant Human erythropoetin (rHuEPO) three times a week can be converted to PegEPO monthly therapy which results in improved anemia control, characterized by a greater increase in hemoglobin levels in patients previously treated with ESAs at extended dosing intervals. This factor should be taken into account when switching to a long-acting ESA, given its potential impact on the risk of hemoglobin overshooting. In MIRACEL study, conversion to PegEPO from Darbepoetin or short acting ESA, was shown to be practical, convenient and offer good control of haemoglobin levels, regardless of the previous type of therapy or dosing frequency [ 56 ]. Also, Monthly CERA maintains hemoglobin stability in hemodialysis patients after switching from epoetin beta; however, its stronger erythropoietic stimulus may be associated with a different effect on anisocytosis. This difference may be attributable to higher circulating erythropoietin levels and more potent suppression of hepcidin. [ 57 ]. In a Japanese study, 61 stable patients on DA or rHuEPO were switched on 4 weekly PegEPO not only led to stable Hb levels, but also decrease in desired dose at 28 weeks [ 58 ]. In a pooled analysis of 13 phase III trials, 2060 patients were included in the analysis. Across all analyzed subgroups, switching from shorter-acting erythropoiesis-stimulating agents to once-monthly continuous erythropoiesis receptor activator maintained stable hemoglobin concentrations in a high proportion of patients (78%), with only moderate hemoglobin fluctuations and a low frequency of dose adjustments [ 59 ]. Hb targets and monitoring Hemoglobin should be monitored every 2-4 weeks after initiation or dose adjustment with PegEPO Monthly Hb monitoring is sufficient after dose stabilization More frequent Hb monitoring (every 2 weeks) may be required during the first two months after switching to PegEPO in some cases Target Hb should be maintained between 10-12 g/dl in patients on PegEPO As per guideline recommendations, hemoglobin levels should be monitored every 2–4 weeks during initiation and dose adjustment. [ 4 ]. Once a month Hb measurement is recommended by KDIGO in the initiation phase of ESA therapy, while in maintenance therapy Hb has to be measured monthly in dialysis therapy and three monthly in non dialysis ones [ 6 ]. Also, as per UK Kidney association guidelines, Hb concentration should be monitored every 2–4 weeks in the correction phase or after a dose adjustment and every 1–3 months for stable individuals in the maintenance phase of ESA treatment. [ 60 ]. The target Hb level for patients on ESA therapy recommended by KDIGO is 11.5 g/dl while Indian Consensus guidelines recommend target of 10–12 g/dl but in no case ESA should be used intentionally to increase Hb beyond 13 g/dl [ 4 , 6 ]. The frequency of ESA dose adjustments should be guided by the rate of hemoglobin increase during the initiation phase of ESA therapy, the stability of hemoglobin levels during maintenance treatment, and the frequency of hemoglobin monitoring. In the outpatient setting, the minimum interval between ESA dose adjustments is generally two weeks, as the effects of most dose changes are unlikely to be evident over a shorter time frame [ 55 ]. Dose consideration The starting dose of PegEPO in denovo/ switch patients should be 50 mcg fortnightly A loading dose of 100 mcg can be considered in patients having Hb <9 g/dl Fortnightly dosing is better than monthly dosing Conversion ratios to PegEPO are well established and practical in real world settings In HD patients, PegEPO should be administered at the end of Dialysis session For patients not achieving the desired Hb level, shortening the dosing interval is preferable than changing the dose In case of dose discrepancy on per kg body weight, the nearest upper mcg dose can be considered for administration The recommended dosing for Pegylated Erythropoetin in CKD anemia is 0.6 mcg/kg body weight fortnightly or 1.2 mcg/kg body weight monthly. However, in real world scenario, converting it to fixed mcg dose for the patient remains a challenge for the physician. In India, PegEPO is available as 30, 50, 75 and 100 mcg injections. In recent KDIGO guidelines, the dose proposed is 50–120 µg every two weeks or 120–200 µg every month in non dialysis patients and 0.6 µg/kg every 2 weeks (may be rounded to nearest upper mcg dose). For titration, in CKD not receiving dialysis- Increase or decrease dose and/or dosing frequency as needed (generally not given more than once every 2 weeks), while in dialysis patients- Increase by 30–50 µg/dose if Hb rise is < 1.0 g/dl ( 2 g/dl (20 g/l) in 4 weeks [ 4 ]. In HEMEPEG study, 30 mcg used weekly resulted in a significant rise in Hb levels in Dialysis dependent patients. [ 11 ]. AFFIRM study evaluated the dose conversion ratio (DCR) in a population of hemodialysis patients who achieved comparable hemoglobin levels after switching from intravenous darbepoetin alfa to intravenous pegylated erythropoietin in a real-world clinical setting [ 61 ]. It concluded that European hemodialysis patients who were converted from darbepoetin alfa to pegylated erythropoietin and completed 6–7 months of post-conversion PEG-Epo therapy, an approximately 20% increase in the microgram dose was required to maintain a comparable hemoglobin profile. The geometric mean DCR of PEG-Epo to DA was 1.17, rising to 1.21 when the effect of Red blood cell (RBC) transfusions was taken into account (61). The monthly dose of PegEPO ranges from 120–360 mcg/month however the individualized dosing becomes difficult with this. Studies have shown that a dose of 75–100 µg/month is enough to maintain stable levels of haemoglobin [ 62 ]. In a Japanese real world study conducted in more than 3000 patients, among patients who transitioned to PegEPO, the most frequent dose conversion patterns varied according to the prior ESA and dialysis modality [ 63 ]. In those switching from recombinant human erythropoietin (rHuEPO), the most common regimens were conversion from erythropoietin < 4500 IU/week to PegEPO 100 µg every 4 weeks in non-dialysis (ND) patients (22.72%), from erythropoietin ≥ 4500 IU/week to PegEPO 150 µg every 4 weeks in hemodialysis (HD) patients (23.04%), and from erythropoietin < 4500 IU/week to PegEPO 100 µg every 4 weeks in peritoneal dialysis (PD) patients. Similarly, among patients switching from darbepoetin alfa, the most frequent conversions were from darbepoetin alfa ≥ 30 to < 40 µg/week to PegEPO 100 µg every 4 weeks in ND patients (10.51%), from darbepoetin alfa ≥ 40 to < 60 µg/week to PegEPO 150 µg every 4 weeks in HD patients (9.51%), and from darbepoetin alfa ≥ 30 to < 40 µg/week to PegEPO 150 µg every 4 weeks in peritoneal dialysis (PD) patients [ 63 ] Considering the local factors and available studies, panel agreed that 50 mcg every 15 days is the optimal dose for Indian patients followed by fortnightly Hb measurement and subsequent dose titration in the dose levels as recommended. If the patients’s Hb is less than 9 g/dl, a loading dose of 100 mcg can be considered and then 50 mcg to be continued as recommended above. In the titration phase, Hb should be measured fortnightly followed by monthly once patient enters the maintenance phase. Studies have shown that switching from EPO therapy to PegEPO without a decline in hemoglobin levels could be achieved by administering PegEPO every two weeks, but not every four weeks [ 64 ]. Additionally it also provides frequent Hb monitoring in the initial phase of switching. There have also been studies conducted to evaluate effects of weekly and biweekly intravenous PegEPO administration on erythropoiesis, showing the weekly administration well tolerated as biweekly in HD patients [ 65 ]. However the conversion should be considered taking into account the factors related to the patient and the stage of CKD. It is a standard practice that ESA should be administered at the end of the dialysis session and same holds true for pegylated EPO as well [ 66 ]. Kawai et al. demonstrated that shortening the PegEPO treatment interval combined with iron supplementation may lead to the more efficient treatment of HD patients with iron deficiency. Panel agreed that shortening the dosing interval compared to dose often allows for more gradual and predictable control over the Hb level, helping to keep it within the desired target range. Additionally it avoids the patient’s load to purchase new dose everytime. To avoid underdosing, the panel agreed that to avoid confusions related to body weight based dosing, the nearest upper mcg strength can be prescribed considering its predictable pharmacokinetics and slow and steady rise in Hb. As mentioned earlier also, initially the dose conversion may seem high but studies have shown that total dose requirements of PegEPO come down overtime, therefore it is not harmful to start with a slightly higher dose [ 66 ] Safety, Outcomes, and Cost If cost is not a concern, Pegylated erythropoietin should be preferred over other ESAs considering its advantages like less frequency of administration, less Hb variability and stable rise in Hb Pegylated EPO has a comparable safety profile to other ESAs Pegylated EPO is cost effective compared to more frequently used thrice weekly ESA injections Pegylated EPO is safe to be used in elderly CKD population as in non elderly PegEPO is safe in patients with previous minor ESA-related adverse events Considering the local geographical and practical challenges, PegEPO seems to be a better option than other long and short acting ESAs In developing countries like India, cost of therapy remains a big concern for the treating physician as it might affect the adherence of the patients [ 67 ]. In a study conducted in maintenance hemodialysis patients, PegEPO showed probability of 0.60 to be cost saving and 0.99 of probability of being cost effective [ 68 ]. In another study in non dialysis patients, in-clinic ESA administration was associated with significant excess annual costs, varying from USD 2,572 per patient for monthly dosing to USD 20,948 per patient for thrice-weekly dosing [ 69 ]. ESA administration incurs both direct and indirect cost including preparation and administration of each dose, as well as other supplies and consumables needed for the application of each drug. When PegEPO administration was compared with thrice weekly rHuEPO administration, there was a trend to reduced total active HCP time when comparing PegEPO vs epoetin alfa administration [ 70 ]. When extrapolated to a full year of ESA therapy (156 administrations for epoetin alfa versus 12 administrations for PegEPO), the estimated staff costs were USD 82.68 (95% CI: 81.12–84.24) for epoetin alfa and USD 4.44 (95% CI: 4.08–4.80) for PegEPO, respectively. [ 70 ]. Therefore, in calculation of the cost of therapy, indirect costs should also be calculated including transportation, injection and other healthcare. In ESAs, one of the most common adverse effects is injection site reactions. Adherence to subcutaneously administered therapies may be adversely affected by frequent injections and injection-site reactions, such as pain. Decreasing the frequency of administrations improves adherence. Additionally, reduced frequency also contributes to less Hb excursions. Therefore, PegEPO in fortnightly/ monthly administration is a fair choice in patients taking s.c injections. India is a vast country and there are multiple challenges concerning ESAs primarily concerning logistics and infrastructure constraints, especially in rural and remote areas. Issues like cold chain management related to challenges like temperature fluctuations, inefficient routes, high operational costs, regulatory compliance issues and price constitute an important part to maintain the compliance to the therapy [ 71 ]. ESAs also require strict cold-chain storage to maintain stability and minimize the risk of immunogenicity, which may limit access in certain regions [ 72 ]. PegEPO advantages like fortnightly or monthly injections and comparable cost improves patient adherence. Additionally, it also reduces the burden on healthcare staff reducing the workload in dialysis centres. Conclusion For both dialysis-dependent (DD) and non-dialysis-dependent (NDD) CKD patients, this consensus offers helpful recommendations for maximizing the use of pegylated erythropoietin (PegEPO) for anemia management. It helps nephrologists expand safe and effective treatment options beyond traditional ESAs by incorporating expert insights and current evidence. These recommendations also emphasize the need for additional local research to boost clinical confidence and guide practice in practical settings, given the paucity of data from Indian populations. Abbreviations CKD Chronic Kidney Disease ESA Erythropoesis Stimulating Agents KDIGO Kidney Disease:Improving Global Outcomes PegEPO Pegylated Erythropoetin DCGI Drug Controller General of India DOPPS Dialysis Outcomes and Practice Patterns Study NDD Non Dialysis Dependent IV Intravenous SC Subcutaneous HD Hemodialysis DA Darbepoetin Alfa DTP Dose-titration period EEP Efficacy evaluation period QOL Quality of life PIVOTAL Proactive, High-Dose versus Reactive, Low-Dose Intravenous Iron Supplementation in Hemodialysis CKD-MBD Chronic Kidney Disease Mineral Bone Disease TSAT Transferrin saturation DD Dialysis Dependent Hb Hemoglobin EPO Erythropoetin rHuEPO Recombinant Human erythropoietin DCR Dose conversion ratio IU International units PD Peritoneal Dialysis Declarations Ethics approval and consent to participate: The survey did not include patient data, just doctors’ opinions, it was completely anonymous, and informed consent was implicit in the heading of the own survey Consent for publication: Consent was obtained from all authors for publication of this manuscript Competing interests: The authors declare that they have no competing interests. Jay Kumar Sharma is an employee of Intas Pharmaceuticals and did not take part in formation of questionnaire or consensus statements. Funding: There was no funding for this research Author Contribution VK, KK, JaK, MH contributed to conception and design of the article. JiK, SS, PK contributed to analysis of the data and formation of tables. SM, RB, RN, RS contributed to the interpretation of data and revision of the article. VS, SG, JS and IM contributed to analysis of the data and drafting of the article. All authors read and approved the final manuscript Data Availability The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request References Ohashi N, Sakao Y, Yasuda H, Kato A, Fujigaki Y. Methoxy polyethylene glycol-epoetin beta for anemia with chronic kidney disease. Int J Nephrol Renovasc Dis. 2012;5:53–60. 10.2147/IJNRD.S23447 . Kim D, Lee J, Toyama T, Liyanage T, Woodward M, Matsushita K, et al. 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Cureus. 2025;17(9):e93584. 10.7759/cureus.93584 . Additional Declarations No competing interests reported. Supplementary Files Supplfile.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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Hospital","correspondingAuthor":false,"prefix":"","firstName":"Iain","middleName":"","lastName":"Macdougall","suffix":""}],"badges":[],"createdAt":"2026-01-27 05:38:45","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8706096/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8706096/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":102748130,"identity":"624c6a1b-682a-4a36-8e98-bc0ce2ebde9b","added_by":"auto","created_at":"2026-02-16 09:06:03","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":49088,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8706096/v1/58b628e985e3708ca34732ce.png"},{"id":102747136,"identity":"026ee4ff-50c7-474b-bcbb-9d216e93cfa5","added_by":"auto","created_at":"2026-02-16 09:03:54","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":69684,"visible":true,"origin":"","legend":"\u003cp\u003eLegend not included with this version.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8706096/v1/8abfef4f68de406b67d94f56.png"},{"id":106960968,"identity":"13f25969-4eb1-493a-a53a-307393988cd5","added_by":"auto","created_at":"2026-04-15 09:23:49","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":990279,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8706096/v1/d63f06b8-8f21-4383-8216-888eab3ec152.pdf"},{"id":102610056,"identity":"e0602eaa-32aa-4ddc-95b6-01df1ed269b1","added_by":"auto","created_at":"2026-02-13 14:40:30","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":16800,"visible":true,"origin":"","legend":"","description":"","filename":"Supplfile.docx","url":"https://assets-eu.researchsquare.com/files/rs-8706096/v1/43fa9c351c84564b7ecdfe52.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Real World Use of Pegylated Erythropoietin in CKD Anemia: An Indian Modified Delphi Consensus","fulltext":[{"header":"Background","content":"\u003cp\u003eChronic Kidney Disease (CKD) remains one of the global concern of the health sector and has long been identified as an independent risk factor for the development of end-stage renal disease, cardiovascular morbidity and mortality [1]. Anemia is one of the frequent manifestations of CKD and largely results from inadequate erythropoietin production, iron deficiency and inflammation, therefore associated with reduced exercise capacity, impaired quality of life, faster CKD progression, higher hospitalization and death rates [2]. In India and the Asian region, the prevalence of renal anemia remains particularly high with reported rate of above 40-70%, and steadily increases with stages of severity of CKD [3, 4].\u003c/p\u003e\n\u003cp\u003eErythropoiesis-Stimulating Agents (ESAs) remain the cornerstone of pharmacotherapy for CKD-induced anemia for more than two decades after correcting underlying reversible causes like iron deficiency anemia and inflammation. [5]. Recent Kidney Disease: Improving Global Outcomes (KDIGO) 2026 anemia guidelines, as well as Consensus guidelines published by Indian Society of Nephrology, recommend judicious use of ESAs to keep hemoglobin levels within a ‘conservative’ target range, taking into account both symptomatic relief and potential risks of excess hemoglobin levels, as well as excessive doses of ESAs. [4, 6]. Conventional ESAs, such as darbepoetin alpha and epoetin alfa, must be administered on a weekly or every two-week basis, are prone to hemoglobin cycling, demand a significant amount of clinic time, and place a significant treatment load on both CKD patients and dialysis center staff. [1, 7, 8].\u003c/p\u003e\n\u003cp\u003eMethoxy polyethylene glycol epoetin beta (pegylated erythropoietin; PegEPO, continuous erythropoietin receptor activator) is a 'third-generation' erythropoiesis-stimulating agent formed by covalent attachment of a methoxy polyethylene glycol chain to the epoetin beta molecule, thereby enormously increasing its half life and the duration of erythropoietin receptor activation. [1]\u003c/p\u003e\n\u003cp\u003eIts very long terminal half life of about 130 hrs for dialysis and nondialysis CKD patients given either subcutaneously and/or intravenously allows its once-monthly maintenance doses to provide more stable levels of hemoglobin. [9]\u003c/p\u003e\n\u003cp\u003ePhase III and post-marketing experience has proved PegEPO to be at least as effective and well-tolerated as conventional erythropoiesis-stimulating agents for both correcting and maintaining renal anemia. Additionally, it also offers longer-dosing intervals and possibly lowers healthcare system load [4].\u003c/p\u003e\n\u003cp\u003eReal world studies conducted on Indian and Asian CKD patients have indicated that effective dose schedules of PegEPO are capable of improving hemoglobin levels. [10,11] In a multi-center observational study conducted in Indian patients (HEMEPEG), significant increases in hemoglobin levels were achieved with weekly or 10-day treatment with 30µg doses of PegEPO, and about 50% of patients achieved hemoglobin levels of 10-12g/dL. [11] One of the important causes for anemia in patients with chronic kidney disease, particularly in dialysis, is erythropoietin resistance. In patients undergoing treatment with erythropoietin, 10% become resistant and require high doses of the drug. [12] Higher doses of ESAs are associated with increased morbidity and mortality. [13] Treatment with PegEPO in patients with chronic kidney disease resulted in a hemoglobin increase comparable to darbepoetin, while requiring a lower therapeutic dose [14].\u003c/p\u003e\n\u003cp\u003eErypeg® (pegylated erythropoietin) is a biosimilar of Mircera® (Innovator pegylated erythropoetin) developed by Intas Pharmaceuticals (India). Its efficacy and safety have been demonstrated in a bioequivalence study involving 126 non-dialysis chronic kidney disease patients [15]. Erypeg® received approval from the Drug Controller General of India (DCGI) in 2016 for the treatment of renal anemia in both dialysis-dependent and non-dialysis-dependent patients, and provides a cost-effective therapeutic option for Indian patients in whom pegylated erythropoietin therapy is indicated.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDespite these benefits, according to Dialysis Outcomes and Practice Patterns Study (DOPPS) study, the usage of PegEPO in CKD anemic patients is just 3-26% [16]. Therefore, this expert consensus was conducted to provide recommendations on usage of PegEPO, focussed to the Indian healthcare context so as to optimize the treatment of anemia in CKD and improve patient outcomes.\u003c/p\u003e"},{"header":"Material and methods","content":"\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003eDevelopment of the Delphi Panel Questionnaire\u003c/h2\u003e \u003cp\u003eFor conducting the expert consensus, an expert panel was constituted comprising of 12 experienced clinicians, all of whom were well qualified nephrologists with each one having more than 15 years of clinical experience in the management of renal anemia. Their professional experience encompassed both hospital-based practice and individual center\u0026ndash;based care. All panellists held clinical leadership positions at their respective institutions.\u003c/p\u003e \u003cp\u003eA steering committee, comprising of three experienced nephrologists was constituted to guide the Delphi process, with additional support provided by other nephrologists to the steering committee.\u003c/p\u003e \u003cp\u003eData from relevant studies evaluating the dosing, efficacy, and safety of pegylated erythropoietin (PegEPO) were shared with the expert panel for review as part of the preparatory phase for the Delphi consensus development. Key topics requiring clinical expertise were identified, discussed, and finalized by the panel chair. These topics included patient selection, dosing strategies, iron management, switching from other erythropoiesis-stimulating agents (ESAs), target hemoglobin levels and monitoring, safety outcomes, and cost considerations.\u003c/p\u003e \u003cp\u003eA pre-meeting reading material was distributed to all panel members to prepare for the meeting, based on these domains. This material mainly focused on data regarding PegEPO's utility in CKD anemia. Subsequently, an advisory board meeting was conducted prior to the Round 1 survey, during which survey-related topics were discussed in detail. Another in-person meeting was used to facilitate structured discussion and raise relevant issues for consideration, consistent with established Delphi methodology. Survey questions were finalized following consultation with the panel chair.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eModified Delphi Panel Survey\u003c/h2\u003e \u003cp\u003eThe Modified Delphi panel survey on the use of pegylated erythropoietin (PegEPO) in CKD-related anemia comprised two in-person meetings and three online survey rounds. The process flow chart is mentioned in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003eConsensus for a statement was predefined as agreement by more than 75% of panelists (\u0026ge;\u0026thinsp;9 of 12), on a 5 point Likert scale. (1-Strongly Disagree, 2-Disagree, 3-Neutral, 4-Agree, 5-Strongly Agree). This was used in all three rounds of polling\u003c/p\u003e \u003cp\u003eRound 1 consisted of 33 online survey questions and was conducted between September 21 and September 30, 2025. Responses were recorded using a Likert scale. Based on the analysis of Round 1 responses, Round 2 was conducted between November 15 and November 30, 2025, and included 21 close-ended online survey questions. This was followed by a second in-person meeting to discuss areas lacking consensus. Round 3 comprised 12 online survey questions. Responses were again obtained in a 5 point likert scale in all three surveys.\u003c/p\u003e \u003cp\u003eBased on inputs provided by the advisors on Likert scale, a total of 31 statements were generated for Round 1 of the Delphi process. These statements were categorized by clinical setting and addressed key domains including patient selection, dosing and administration, iron management, switching from other erythropoiesis-stimulating agents (ESAs), hemoglobin targets and management, safety outcomes, and cost considerations.\u003c/p\u003e \u003cp\u003eIn Round 1, consensus was achieved for 10 of the 31 statements. Statements that did not reach consensus were reviewed, refined, and subsequently included in Round 2, which was conducted online. Round 2 comprised six modified statements derived from Round 1, all of which achieved consensus. Overall, consensus was achieved for 13 of 26 statements evaluated in Round 2.\u003c/p\u003e \u003cp\u003eFollowing the two survey rounds, an in-person advisory board meeting was conducted in Dec\u0026rsquo; 25 and topics which were not having consensus in two rounds were discussed. In round 3, 14 statements were subjected to live polling. Consensus was achieved for 12 of these statements. (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv class=\"gridtable\"\u003e\n\u003cdiv class=\"colspec\" align=\"left\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003cdiv class=\"colspec\" align=\"char\"\u003e\u0026nbsp;\u003c/div\u003e\n\u003ctable id=\"Taba\" border=\"1\"\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eFinal recommendation/statement\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eConsensus* (%)\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003ePatient Selection\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLong acting ESA is the first choice as ESA for anemia management in non dialysis dependent (NDD) patients\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eDe novo patients are more suitable for PegEPO therapy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e75\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegylated erythropoetin is suitable for switch patients from short acting ESAs\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegylated erythropoetin can be considered the first-line ESA in CKD stage 5D patients\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e75\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePatients who need ESA conversion from intravenous (IV) to subcutaneous (SC) are more suitable to PegEPO therapy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e92\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegylated erythropoetin is safe to use in elderly CKD patients without dose adjustments beyond standard recommendation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eESA hyporesponsive patients should be prescribed PegEPO as ESA therapy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePatients who frequently misses their ESA injections and have poor compliance can be shifted to PegEPO\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegEPO provides better haemoglobin (Hb) stabilization compared to short acting ESAs\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e92\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eIron Management\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFerritin\u0026thinsp;\u0026gt;\u0026thinsp;200 ng/mL and Transferrin saturation (TSAT)\u0026thinsp;\u0026gt;\u0026thinsp;20% should be ensured before initiating PegEPO\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e92\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIV iron should be administered proactively in all Dialysis dependent patients to be initiated on PegEPO\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e92\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePatients with stable iron stores (TSAT\u0026thinsp;\u0026ge;\u0026thinsp;25% and ferritin\u0026thinsp;\u0026ge;\u0026thinsp;200 ng/mL) are more likely to have predictable response to pegylated erythropoetin\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCombining PegEPO with IV iron during the same visit improves patient compliance and outcomes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e92\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eSwitching from Other ESAs\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eA once-monthly dosing frequency improves patient adherence and clinic workflow.\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLonger dosing intervals with PegEPO reduce the risk of Hemoglobin variability associated adverse outcomes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePatients with Hb variability or requiring frequent dose changes on Darbepoetin/ short acting ESAs should be shifted to PegEPO\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePatients with stabilized Hb on fortnightly ESA injections can be considered for safely switching to monthly PegEPO without compromising anemia control\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegEPO is able to maintain Hb levels when administered once every 2\u0026ndash;4 weeks, subcutaneous or intravenous, in patients who were previously maintained on EPO alpha or Darbepoetin\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eHb Targets \u0026amp; Monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHemoglobin should be monitored every 2 weeks after initiation or dose adjustment with PegEPO\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e75\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMonthly Hb monitoring is sufficient after dose stabilization\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMore frequent Hb monitoring (every 2 weeks) is required during the first two months after switching to PegEPO\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eTarget Hb should be maintained between 10\u0026ndash;12 g/dl in patients on PegEPO\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eDose consideration\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eThe starting dose of PegEPO in denovo/ switch patients should be 50 mcg fortnightly\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e93\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eA loading dose of 100 mcg can be considered in patients having Hb\u0026thinsp;\u0026lt;\u0026thinsp;9 g/dl\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e93\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFortnighly dosing is better than monthly dosing\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e93\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eConversion ratios to PegEPO are well established and practical in real world settings\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIn Hemodialysis (HD) patients, PegEPO should be administered at the end of Dialysis session\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFor patients not achieving the desired Hb level, shortening the dosing interval is preferable than changing the dose\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIn case of dose discrepancy on per kg body weight, the nearest upper mcg dose can be considered for administration\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eSafety, Outcomes, and Cost\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eIf cost is not a concern, Pegylated erythropoietin should be preferred over other ESAs considering its advantages like less frequency of administration, less Hb variability and stable rise in Hb\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegylated EPO has a comparable safety profile to other ESAs\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e83\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegylated EPO is cost effective compared to more frequently used thrice weekly ESA injections\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e75\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegylated EPO is safe to use in elderly CKD population\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePegEPO is safe in patients with previous minor ESA-related adverse events\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eConsidering the local geographical and practical challenges, PegEPO seems to be a better option than other long and short acting ESAs in Indian healthcare settings\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e93\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003ch3\u003eConsensus statements\u003c/h3\u003e\n\u003cp\u003e\u003cstrong\u003ePatient selection\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eLong acting ESA is the first choice as ESA in non dialysis dependent (NDD) patients\u003c/li\u003e\n\u003cli\u003eDe novo patients are more suitable for PegEPO therapy\u003c/li\u003e\n\u003cli\u003ePegylated EPO can be considered the first-line ESA in CKD stage 5D patients\u003c/li\u003e\n\u003cli\u003ePegylated EPO is suitable for switch patients from short acting ESAs\u003c/li\u003e\n\u003cli\u003ePatients who need ESA conversion from IV to SC are more suitable to PegEPO therapy\u003c/li\u003e\n\u003cli\u003ePegylated EPO is safe to use in elderly CKD patients without dose adjustments beyond standard recommendation\u003c/li\u003e\n\u003cli\u003eESA hyporesponsive patients should be prescribed PegEPO as ESA therapy\u003c/li\u003e\n\u003cli\u003ePatients who frequently miss their ESA injections and have poor compliance can be shifted to ESA therapy\u003c/li\u003e\n\u003cli\u003ePegEPO provides better Hb stabilization compared to short acting ESAs\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThe prevalence of anemia grows as the stage of CKD progresses from 40% in stage 3 to 70% in stage 5. [\u003cspan class=\"CitationRef\"\u003e17\u003c/span\u003e]. Due to high inflammation and functional iron deficiency, symptoms of anemia are more severe in dialysis patients than non dialysis. Prevalence of anemia in stage 3a-5 CKD is 39.6% according to a study conducted by Minutolo et al. [\u003cspan class=\"CitationRef\"\u003e18\u003c/span\u003e]. However, as per CKDoPPS study, 68% of NDD patients neither receive Iron nor ESA for their anemia management [\u003cspan class=\"CitationRef\"\u003e19\u003c/span\u003e]. Furthermore, patients with stage 4 and stage 5 CKD appear to be undertreated, where only 24% and 32% of individuals receive any form of treatment respectively. [\u003cspan class=\"CitationRef\"\u003e20\u003c/span\u003e]. Majority of NDD patients suffer from mild to moderate anemia [\u003cspan class=\"CitationRef\"\u003e21\u003c/span\u003e]. A discrete choice experiment carried out with Non-Dialysis-Dependent CKD anemic patients found that those with anaemia regard the method and frequency of treatment administration as a significant factor. [\u003cspan class=\"CitationRef\"\u003e22\u003c/span\u003e]. Longer acting ESAs administered weekly or fortnightly is a preferable choice compared to three times short acting ESA administration, particularly in non dialysis patients.\u003c/p\u003e\n\u003cp\u003ePegylated Erythropoetin has shown its efficacy in de novo patients in multiple clinical trials. In CORDATUS trial, the Hb response rate with monthly injection was 94.1%, which was significantly higher than the protocol-specified 60% and was comparable to Darbepoetin. It was also non inferior to Darbepoetin in Hb rise at 28 weeks. Safety profile was also similar in both the arms [\u003cspan class=\"CitationRef\"\u003e23\u003c/span\u003e]. In ARCTOS trial, Hb response rates with Pegylated Erythropoetin was similar to Darbepoetin in de novo NDD patients. PegEPO injection once every 2 week was as effective as darbepoetin alfa once weekly for correcting anemia. [\u003cspan class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003ePegylated erythropoietin has been tested in multiple trials when patients stable on other ESAs were switched to PegEPO therapy. In phase III STRIATA trial, efficacy and safety of intravenous PegEPO administered once every 2 weeks (Q2W) was evaluated for Hb maintenance following direct conversion from darbepoetin alfa (DA) [\u003cspan class=\"CitationRef\"\u003e25\u003c/span\u003e]. The mean difference in the primary endpoint was clinically non inferior to DA and both the therapies were well tolerated. The MAXIMA and PROTOS studies evaluated the efficacy of PegEPO administered via intravenous and subcutaneous routes, respectively, in maintaining haemoglobin levels in haemodialysis patients previously treated with epoetin. [\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e]. In MAXIMA, 673 patients receiving intravenous epoetin once or three times weekly were randomised to continue epoetin or to switch to intravenous PegEPO administered every 2 or 4 weeks. Similarly, the PROTOS study randomised 572 patients receiving subcutaneous epoetin to continue epoetin or to receive subcutaneous PegEPO every 2 or 4 weeks. Both studies demonstrated that pegylated erythropoetin, administered once monthly, maintained haemoglobin concentrations within the target range with efficacy comparable to conventional epoetin therapy, supporting its effectiveness in the management of anaemia in chronic haemodialysis patients [\u003cspan class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e27\u003c/span\u003e] In a real-world study, 127 dialysis-dependent patients receiving conventional erythropoiesis-stimulating agents were switched to a once-monthly pegylated erythropoietin regimen. Monthly administration of PegEPO maintained stable haemoglobin concentrations with an acceptable safety profile. A median monthly dose reduction was also observed, decreasing from 120 \u0026micro;g during the dose-titration period (DTP) to 100 \u0026micro;g during the efficacy evaluation period (EEP) [\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eIn HD patients, vascular access allows the convenience for intravenous administration of ESAs. However, there are two choices in NDD i.e subcutaneous or intravenous. In non-haemodialysis patients, the subcutaneous route may be more convenient due to the absence of continuous intravenous access, ease of self-administration, lower dose requirements, fewer hospital visits, reduced dosing frequency, and overall lower treatment costs. [\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e]. Studies have also demonstrated that shifting the patients from IV to S.C injection results in significant cost benefit to the patients and total ESA dose reduction [\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e]. Since PegEPO provides the convenience of fortnightly or monthly administration with comparable efficacy and safety, it can be considered as a preferred choice over other existing ESAs.\u003c/p\u003e\n\u003cp\u003eIn a study conducted in a geriatric population (\u0026gt;\u0026thinsp;65 years) suffering from chronic anemia, ESA therapy was associated with increases in Hb and improvements in fatigue and quality of life (QOL) [\u003cspan class=\"CitationRef\"\u003e30\u003c/span\u003e]. In a recent meta analysis, patients receiving higher doses of erythropoiesis-stimulating agents (75,000, 100,000, and 200,000 U/week) had progressively increased mortality risks, with hazard ratios of 1.85 (95% CI: 1.55\u0026ndash;2.23), 1.89 (95% CI: 1.53\u0026ndash;2.30), and 2.07 (95% CI: 1.46\u0026ndash;2.95), respectively. [\u003cspan class=\"CitationRef\"\u003e31\u003c/span\u003e]. Also, high dose of ESA independently predicted cardiovascular mortality and mortality from all causes (31). Recently published studies have shown that conversion from short half-life erythropoiesis-stimulating agents to once-monthly subcutaneous PegEPO in pre-dialysis CKD patients effectively maintained haemoglobin levels, with a significant reduction in dose requirements. [\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e]. In MINERVA study, conversion from shorter-acting erythropoiesis-stimulating agents to PegEPO at doses lower than those recommended effectively maintained target haemoglobin levels in both non-dialysis and haemodialysis CKD patients, particularly among those previously receiving higher ESA doses [\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e]. Therefore, in geriatric populations, switching to PegEPO might provide benefits in terms of dose reduction and reduced morbidity\u003c/p\u003e\n\u003cp\u003eESA hyporesponsiveness is commonly defined as the requirement for high ESA doses to maintain haemoglobin levels within the target range, or the failure to achieve target haemoglobin despite such dosing. Patient receiving epoetin, 450 U/kg per week, with Hb level of 100 g/L would have an ESA resistance index of 4.5 [\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e]. The prevalence varies from 5\u0026ndash;20% in HD population [\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e]. There are many causes associated with ESA hyporesponsiveness, important ones being iron deficiency, inflammation, uremia, Chronic Kidney Disease Mineral Bone Disease (CKD- MBD), malnutrition, inadequate dialysis, marrow failure etc. [\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e]. ESA hyporesponsiveness has been associated with thrombotic events in dialysis patients. [\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e]. Since increasing the doses in ESA hyporesponsive patients increases the cardiovascular morbidity, the panel agreed to switch to PegEPO to observe the response before giving supramaximal doses of short acting ESAs. However, evaluating the Hb response after a time period of 2 months appears to be appropriate after initiating PegEPO therapy [\u003cspan class=\"CitationRef\"\u003e37\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003eIt is seen that approximately 90% of hemodialysis patients experience significant fluctuations in Hb levels over time [\u003cspan class=\"CitationRef\"\u003e38\u003c/span\u003e]. Greater fluctuations in hemoglobin levels during treatment with erythropoiesis-stimulating agents (ESAs) are associated with a higher risk of infections, thrombotic complications, and all-cause mortality in patients undergoing hemodialysis [\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e]. Studies have shown that Hb variability has been associated with mortality in ND patients and is independent of the absolute Hb level, change in Hb level over time, and ESA use. The increased hemoglobin variability observed in patients receiving ESAs is likely multifactorial, arising from factors such as the drug\u0026rsquo;s half-life and dosing practices, fluctuations in patient clinical status, and changes in iron availability. [\u003cspan class=\"CitationRef\"\u003e39\u003c/span\u003e] ESA dosing/frequency and administration route (intravenous, subcutaneous) is an important factor contributing to haemoglobin variability in patients with CKD [\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e]. Some studies suggest that long-acting ESAs may reduce hemoglobin variability by allowing less frequent dosing and promoting more stable erythropoiesis; however, other reports show no significant difference, or even greater hemoglobin variability with certain agents [\u003cspan class=\"CitationRef\"\u003e41\u003c/span\u003e]. However, long-acting agents are generally presumed to maintain more stable hemoglobin levels\u0026mdash;due to fewer dose adjustments and less frequent injections than short or intermediate-acting agents. In clinical environments characterized by high provider workload and fewer reimbursement constraints on ESA use, long-acting ESAs may be favoured in these settings. Switch to different types of ESA (e.g., longer acting ESA for noncompliant patients with frequent missing of dialysis treatments) seems to be a fair option for reducing Hb excursions in certain patients. [\u003cspan class=\"CitationRef\"\u003e40\u003c/span\u003e], rather than keep on increasing or decreasing the dosage of same ESA in the patient.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIron Management\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eFerritin \u0026gt;200 ng/mL and TSAT \u0026gt;20% should be ensured before initiating PegEPO\u003c/li\u003e\n\u003cli\u003eIV iron should be administered proactively in all Dialysis Dependent patients initiated on PegEPO\u003c/li\u003e\n\u003cli\u003ePatients with stable iron stores (TSAT \u0026ge;25% and ferritin \u0026ge;200 ng/mL) are more likely to have predictable response to PegEPO\u003c/li\u003e\n\u003cli\u003eCombining PegEPO with IV iron during the same visit improves patient compliance and outcomes\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eIron deficiency is one of the most important causes of ESA hypo responsiveness. [\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e] Therefore, guidelines suggest checking the iron stores before initiating ESA therapy. [\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e] Iron deficiency can be either absolute or functional, therefore, correcting the body iron stores before increasing the ESA doses is a recommended step in anemia management in CKD.\u003c/p\u003e\n\u003cp\u003eVarious clinical studies have supported the proactive iron dose therapy over reactive one. In Proactive, High-Dose versus Reactive, Low-Dose Intravenous Iron Supplementation in Hemodialysis (PIVOTAL) trial, conducted in HD patients, a proactive strategy was superior to a reactive low-dose regimen and resulted in the use of lower overall doses of erythropoiesis-stimulating agents [\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e]. The median monthly dose of erythropoiesis-stimulating agent was 19.4% lower in patients receiving the high-dose regimen [\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e]. Additionally in this trial, high-dose regimen of intravenous iron administered proactively resulted in a significantly lower risk of death or major nonfatal cardiovascular events as compared with that observed with a reactive, low-dose regimen. [\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003eSufficient iron availability is crucial for effective erythropoiesis, as both absolute and functional iron deficiency significantly contribute to ESA hyporesponsiveness and hemoglobin variability in populations with chronic kidney disease and those undergoing hemodialysis. [\u003cspan class=\"CitationRef\"\u003e43\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003eClinical practice guidelines suggest that in hemodialysis patients, TSAT should be maintained above approximately 20\u0026ndash;25% and ferritin levels should exceed 200 ng/mL to guarantee an adequate iron supply to the bone marrow, thereby optimizing the erythropoietic response to ESA therapy [\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003eThese established thresholds are indicative of targets associated with enhanced hemoglobin responses and a decrease in the need for higher ESA dosing, while lower levels of TSAT or ferritin are linked to diminish iron availability and compromised erythropoietic responsiveness.\u003c/p\u003e\n\u003cp\u003eCarelessness and insufficient disease-related information are frequently blamed for non-adherence in NDD patients [\u003cspan class=\"CitationRef\"\u003e45\u003c/span\u003e]. The presence of a central venous catheter, the actual dialysis day, procedural discomfort, the most recent advice from medical professionals, and the frequency of counselling, on the other hand, have a significant impact on compliance among dialysis-dependent (DD) patients [\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e]. Perception of the importance of treatment adherence was missing in the patients in the study [\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e]. Considering all the factors discussed, healthcare professionals should individualize interventions according to patients\u0026rsquo; specific risk profiles, with the goal of enhancing patients\u0026rsquo; perception of the importance of treatment adherence, and combining both ESAs and Iron in a single session might improve adherence to ESA therapy. Additionally, Intravenous iron may also aid with overcoming ESA resistance that has been observed when an ESA has been used without concomitant IV iron [\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003eSwitching from Other ESAs\u003c/h3\u003e\n\u003cul\u003e\n\u003cli\u003eA once-monthly dosing frequency improves patient adherence and clinic workflow.\u003c/li\u003e\n\u003cli\u003eLonger dosing intervals with PegEPO reduce the risk of Hb variability\u0026ndash;associated adverse outcomes\u003c/li\u003e\n\u003cli\u003ePatients with Hb variability or requiring frequent dose changes on Darbepoetin/ short acting ESAs should be shifted to PegEPO\u003c/li\u003e\n\u003cli\u003ePatients with stabilized Hb on fortnightly ESAs can be considered for safely switching to monthly PegEPO without compromising anemia control\u003c/li\u003e\n\u003cli\u003ePegEPO is able to maintain Hb levels when administered once every 2-4 weeks SC or IV, in patients who were previously maintained on erythropoetin alpha or Darbepoetin\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eDosing frequency undoubtedly has a significant impact on patients' adherence. Reducing the frequency of dosing improved adherence to oral therapies, according to a meta-analysis [\u003cspan class=\"CitationRef\"\u003e48\u003c/span\u003e]. Once-weekly dosing was linked to better patient adherence to therapy than once-daily dosing, according to another study that examined the relationship between intermittent dosing and adherence [\u003cspan class=\"CitationRef\"\u003e49\u003c/span\u003e]. One way to increase the effectiveness of care is to use ESAs at longer dosage intervals. Once-monthly dosing reduces the amount of time needed to administer and monitor therapy and enables nephrology specialists to provide comprehensive renal care where the patient takes precedence over task-oriented procedures [\u003cspan class=\"CitationRef\"\u003e50\u003c/span\u003e]. Changes in ESA dosage or clinical events are often linked to hemoglobin variability. Compared to short-acting EPO, long-acting ESA produced greater hemoglobin stability. (26) Research has indicated that a sharp increase in hemoglobin levels is linked to poorer cardiovascular outcomes. [\u003cspan class=\"CitationRef\"\u003e51\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e52\u003c/span\u003e]. Within dosing intervals unique to each ESA class, the maximum efficacy of ESAs is attained [\u003cspan class=\"CitationRef\"\u003e53\u003c/span\u003e]. Epoetin alfa's effectiveness decreases in hemodialysis patients receiving short-acting ESAs subcutaneously or intravenously when the dosage is lowered from three times weekly to once weekly, and it further declines when the interval is increased to every other week [\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e]. On the other hand, long-acting ESAs exhibit optimal efficacy at longer, agent-specific intervals: pegylated erythropoetin exhibits maximal efficacy with once-monthly (every four weeks) dosing, while darbepoetin alfa appears to be most effective when given every two weeks [\u003cspan class=\"CitationRef\"\u003e54\u003c/span\u003e]. Differences in pharmacokinetic characteristics, especially drug half-life, must be carefully taken into account when transferring patients from short-acting to long-acting ESAs [\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e]. For example, conversion from thrice-weekly epoetin alfa to once-monthly PegEPO has been shown to substantially reduce injection frequency while maintaining hemoglobin concentrations within the recommended target range in patients with chronic kidney disease. Multiple studies have confirmed that patients on stable Darbepoetin weekly or Recombinant Human erythropoetin (rHuEPO) three times a week can be converted to PegEPO monthly therapy which results in improved anemia control, characterized by a greater increase in hemoglobin levels in patients previously treated with ESAs at extended dosing intervals. This factor should be taken into account when switching to a long-acting ESA, given its potential impact on the risk of hemoglobin overshooting. In MIRACEL study, conversion to PegEPO from Darbepoetin or short acting ESA, was shown to be practical, convenient and offer good control of haemoglobin levels, regardless of the previous type of therapy or dosing frequency [\u003cspan class=\"CitationRef\"\u003e56\u003c/span\u003e]. Also, Monthly CERA maintains hemoglobin stability in hemodialysis patients after switching from epoetin beta; however, its stronger erythropoietic stimulus may be associated with a different effect on anisocytosis. This difference may be attributable to higher circulating erythropoietin levels and more potent suppression of hepcidin. [\u003cspan class=\"CitationRef\"\u003e57\u003c/span\u003e]. In a Japanese study, 61 stable patients on DA or rHuEPO were switched on 4 weekly PegEPO not only led to stable Hb levels, but also decrease in desired dose at 28 weeks [\u003cspan class=\"CitationRef\"\u003e58\u003c/span\u003e]. In a pooled analysis of 13 phase III trials, 2060 patients were included in the analysis. Across all analyzed subgroups, switching from shorter-acting erythropoiesis-stimulating agents to once-monthly continuous erythropoiesis receptor activator maintained stable hemoglobin concentrations in a high proportion of patients (78%), with only moderate hemoglobin fluctuations and a low frequency of dose adjustments [\u003cspan class=\"CitationRef\"\u003e59\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHb targets and monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eHemoglobin should be monitored every 2-4 weeks after initiation or dose adjustment with PegEPO\u003c/li\u003e\n\u003cli\u003eMonthly Hb monitoring is sufficient after dose stabilization\u003c/li\u003e\n\u003cli\u003eMore frequent Hb monitoring (every 2 weeks) may be required during the first two months after switching to PegEPO in some cases\u003c/li\u003e\n\u003cli\u003eTarget Hb should be maintained between 10-12 g/dl in patients on PegEPO\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eAs per guideline recommendations, hemoglobin levels should be monitored every 2\u0026ndash;4 weeks during initiation and dose adjustment. [\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e]. Once a month Hb measurement is recommended by KDIGO in the initiation phase of ESA therapy, while in maintenance therapy Hb has to be measured monthly in dialysis therapy and three monthly in non dialysis ones [\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e]. Also, as per UK Kidney association guidelines, Hb concentration should be monitored every 2\u0026ndash;4 weeks in the correction phase or after a dose adjustment and every 1\u0026ndash;3 months for stable individuals in the maintenance phase of ESA treatment. [\u003cspan class=\"CitationRef\"\u003e60\u003c/span\u003e]. The target Hb level for patients on ESA therapy recommended by KDIGO is 11.5 g/dl while Indian Consensus guidelines recommend target of 10\u0026ndash;12 g/dl but in no case ESA should be used intentionally to increase Hb beyond 13 g/dl [\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eThe frequency of ESA dose adjustments should be guided by the rate of hemoglobin increase during the initiation phase of ESA therapy, the stability of hemoglobin levels during maintenance treatment, and the frequency of hemoglobin monitoring. In the outpatient setting, the minimum interval between ESA dose adjustments is generally two weeks, as the effects of most dose changes are unlikely to be evident over a shorter time frame [\u003cspan class=\"CitationRef\"\u003e55\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDose consideration\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eThe starting dose of PegEPO in denovo/ switch patients should be 50 mcg fortnightly\u003c/li\u003e\n\u003cli\u003eA loading dose of 100 mcg can be considered in patients having Hb \u0026lt;9 g/dl\u003c/li\u003e\n\u003cli\u003eFortnightly dosing is better than monthly dosing\u003c/li\u003e\n\u003cli\u003eConversion ratios to PegEPO are well established and practical in real world settings\u003c/li\u003e\n\u003cli\u003eIn HD patients, PegEPO should be administered at the end of Dialysis session\u003c/li\u003e\n\u003cli\u003eFor patients not achieving the desired Hb level, shortening the dosing interval is preferable than changing the dose\u003c/li\u003e\n\u003cli\u003eIn case of dose discrepancy on per kg body weight, the nearest upper mcg dose can be considered for administration\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe recommended dosing for Pegylated Erythropoetin in CKD anemia is 0.6 mcg/kg body weight fortnightly or 1.2 mcg/kg body weight monthly. However, in real world scenario, converting it to fixed mcg dose for the patient remains a challenge for the physician. In India, PegEPO is available as 30, 50, 75 and 100 mcg injections. In recent KDIGO guidelines, the dose proposed is 50\u0026ndash;120 \u0026micro;g every two weeks or 120\u0026ndash;200 \u0026micro;g every month in non dialysis patients and 0.6 \u0026micro;g/kg every 2 weeks (may be rounded to nearest upper mcg dose). For titration, in CKD not receiving dialysis- Increase or decrease dose and/or dosing frequency as needed (generally not given more than once every 2 weeks), while in dialysis patients- Increase by 30\u0026ndash;50 \u0026micro;g/dose if Hb rise is \u0026lt;\u0026thinsp;1.0 g/dl (\u0026lt;\u0026thinsp;10 g/l) in 4 weeks and reduce by 30\u0026ndash;50 \u0026micro;g/dose if Hb rise is \u0026gt;\u0026thinsp;2 g/dl (20 g/l) in 4 weeks [\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e]. In HEMEPEG study, 30 mcg used weekly resulted in a significant rise in Hb levels in Dialysis dependent patients. [\u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e]. AFFIRM study evaluated the dose conversion ratio (DCR) in a population of hemodialysis patients who achieved comparable hemoglobin levels after switching from intravenous darbepoetin alfa to intravenous pegylated erythropoietin in a real-world clinical setting [\u003cspan class=\"CitationRef\"\u003e61\u003c/span\u003e]. It concluded that European hemodialysis patients who were converted from darbepoetin alfa to pegylated erythropoietin and completed 6\u0026ndash;7 months of post-conversion PEG-Epo therapy, an approximately 20% increase in the microgram dose was required to maintain a comparable hemoglobin profile. The geometric mean DCR of PEG-Epo to DA was 1.17, rising to 1.21 when the effect of Red blood cell (RBC) transfusions was taken into account (61). The monthly dose of PegEPO ranges from 120\u0026ndash;360 mcg/month however the individualized dosing becomes difficult with this. Studies have shown that a dose of 75\u0026ndash;100 \u0026micro;g/month is enough to maintain stable levels of haemoglobin [\u003cspan class=\"CitationRef\"\u003e62\u003c/span\u003e]. In a Japanese real world study conducted in more than 3000 patients, among patients who transitioned to PegEPO, the most frequent dose conversion patterns varied according to the prior ESA and dialysis modality [\u003cspan class=\"CitationRef\"\u003e63\u003c/span\u003e]. In those switching from recombinant human erythropoietin (rHuEPO), the most common regimens were conversion from erythropoietin\u0026thinsp;\u0026lt;\u0026thinsp;4500 IU/week to PegEPO 100 \u0026micro;g every 4 weeks in non-dialysis (ND) patients (22.72%), from erythropoietin\u0026thinsp;\u0026ge;\u0026thinsp;4500 IU/week to PegEPO 150 \u0026micro;g every 4 weeks in hemodialysis (HD) patients (23.04%), and from erythropoietin\u0026thinsp;\u0026lt;\u0026thinsp;4500 IU/week to PegEPO 100 \u0026micro;g every 4 weeks in peritoneal dialysis (PD) patients. Similarly, among patients switching from darbepoetin alfa, the most frequent conversions were from darbepoetin alfa\u0026thinsp;\u0026ge;\u0026thinsp;30 to \u0026lt;\u0026thinsp;40 \u0026micro;g/week to PegEPO 100 \u0026micro;g every 4 weeks in ND patients (10.51%), from darbepoetin alfa\u0026thinsp;\u0026ge;\u0026thinsp;40 to \u0026lt;\u0026thinsp;60 \u0026micro;g/week to PegEPO 150 \u0026micro;g every 4 weeks in HD patients (9.51%), and from darbepoetin alfa\u0026thinsp;\u0026ge;\u0026thinsp;30 to \u0026lt;\u0026thinsp;40 \u0026micro;g/week to PegEPO 150 \u0026micro;g every 4 weeks in peritoneal dialysis (PD) patients [\u003cspan class=\"CitationRef\"\u003e63\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003eConsidering the local factors and available studies, panel agreed that 50 mcg every 15 days is the optimal dose for Indian patients followed by fortnightly Hb measurement and subsequent dose titration in the dose levels as recommended. If the patients\u0026rsquo;s Hb is less than 9 g/dl, a loading dose of 100 mcg can be considered and then 50 mcg to be continued as recommended above. In the titration phase, Hb should be measured fortnightly followed by monthly once patient enters the maintenance phase. Studies have shown that switching from EPO therapy to PegEPO without a decline in hemoglobin levels could be achieved by administering PegEPO every two weeks, but not every four weeks [\u003cspan class=\"CitationRef\"\u003e64\u003c/span\u003e]. Additionally it also provides frequent Hb monitoring in the initial phase of switching. There have also been studies conducted to evaluate effects of weekly and biweekly intravenous PegEPO administration on erythropoiesis, showing the weekly administration well tolerated as biweekly in HD patients [\u003cspan class=\"CitationRef\"\u003e65\u003c/span\u003e]. However the conversion should be considered taking into account the factors related to the patient and the stage of CKD.\u003c/p\u003e\n\u003cp\u003eIt is a standard practice that ESA should be administered at the end of the dialysis session and same holds true for pegylated EPO as well [\u003cspan class=\"CitationRef\"\u003e66\u003c/span\u003e]. Kawai et al. demonstrated that shortening the PegEPO treatment interval combined with iron supplementation may lead to the more efficient treatment of HD patients with iron deficiency. Panel agreed that shortening the dosing interval compared to dose often allows for more gradual and predictable control over the Hb level, helping to keep it within the desired target range. Additionally it avoids the patient\u0026rsquo;s load to purchase new dose everytime.\u003c/p\u003e\n\u003cp\u003eTo avoid underdosing, the panel agreed that to avoid confusions related to body weight based dosing, the nearest upper mcg strength can be prescribed considering its predictable pharmacokinetics and slow and steady rise in Hb. As mentioned earlier also, initially the dose conversion may seem high but studies have shown that total dose requirements of PegEPO come down overtime, therefore it is not harmful to start with a slightly higher dose [\u003cspan class=\"CitationRef\"\u003e66\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSafety, Outcomes, and Cost\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eIf cost is not a concern, Pegylated erythropoietin should be preferred over other ESAs considering its advantages like less frequency of administration, less Hb variability and stable rise in Hb\u003c/li\u003e\n\u003cli\u003ePegylated EPO has a comparable safety profile to other ESAs\u003c/li\u003e\n\u003cli\u003ePegylated EPO is cost effective compared to more frequently used thrice weekly ESA injections\u003c/li\u003e\n\u003cli\u003ePegylated EPO is safe to be used in elderly CKD population as in non elderly\u003c/li\u003e\n\u003cli\u003ePegEPO is safe in patients with previous minor ESA-related adverse events\u003c/li\u003e\n\u003cli\u003eConsidering the local geographical and practical challenges, PegEPO seems to be a better option than other long and short acting ESAs\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eIn developing countries like India, cost of therapy remains a big concern for the treating physician as it might affect the adherence of the patients [\u003cspan class=\"CitationRef\"\u003e67\u003c/span\u003e]. In a study conducted in maintenance hemodialysis patients, PegEPO showed probability of 0.60 to be cost saving and 0.99 of probability of being cost effective [\u003cspan class=\"CitationRef\"\u003e68\u003c/span\u003e]. In another study in non dialysis patients, in-clinic ESA administration was associated with significant excess annual costs, varying from USD 2,572 per patient for monthly dosing to USD 20,948 per patient for thrice-weekly dosing [\u003cspan class=\"CitationRef\"\u003e69\u003c/span\u003e]. ESA administration incurs both direct and indirect cost including preparation and administration of each dose, as well as other supplies and consumables needed for the application of each drug. When PegEPO administration was compared with thrice weekly rHuEPO administration, there was a trend to reduced total active HCP time when comparing PegEPO vs epoetin alfa administration [\u003cspan class=\"CitationRef\"\u003e70\u003c/span\u003e]. When extrapolated to a full year of ESA therapy (156 administrations for epoetin alfa versus 12 administrations for PegEPO), the estimated staff costs were USD 82.68 (95% CI: 81.12\u0026ndash;84.24) for epoetin alfa and USD 4.44 (95% CI: 4.08\u0026ndash;4.80) for PegEPO, respectively. [\u003cspan class=\"CitationRef\"\u003e70\u003c/span\u003e]. Therefore, in calculation of the cost of therapy, indirect costs should also be calculated including transportation, injection and other healthcare.\u003c/p\u003e\n\u003cp\u003eIn ESAs, one of the most common adverse effects is injection site reactions. Adherence to subcutaneously administered therapies may be adversely affected by frequent injections and injection-site reactions, such as pain. Decreasing the frequency of administrations improves adherence. Additionally, reduced frequency also contributes to less Hb excursions. Therefore, PegEPO in fortnightly/ monthly administration is a fair choice in patients taking s.c injections.\u003c/p\u003e\n\u003cp\u003eIndia is a vast country and there are multiple challenges concerning ESAs primarily concerning logistics and infrastructure constraints, especially in rural and remote areas. Issues like cold chain management related to challenges like temperature fluctuations, inefficient routes, high operational costs, regulatory compliance issues and price constitute an important part to maintain the compliance to the therapy [\u003cspan class=\"CitationRef\"\u003e71\u003c/span\u003e]. ESAs also require strict cold-chain storage to maintain stability and minimize the risk of immunogenicity, which may limit access in certain regions [\u003cspan class=\"CitationRef\"\u003e72\u003c/span\u003e]. PegEPO advantages like fortnightly or monthly injections and comparable cost improves patient adherence. Additionally, it also reduces the burden on healthcare staff reducing the workload in dialysis centres.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eFor both dialysis-dependent (DD) and non-dialysis-dependent (NDD) CKD patients, this consensus offers helpful recommendations for maximizing the use of pegylated erythropoietin (PegEPO) for anemia management. It helps nephrologists expand safe and effective treatment options beyond traditional ESAs by incorporating expert insights and current evidence. These recommendations also emphasize the need for additional local research to boost clinical confidence and guide practice in practical settings, given the paucity of data from Indian populations.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eCKD\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eChronic Kidney Disease\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eESA\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eErythropoesis Stimulating Agents\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eKDIGO\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eKidney Disease:Improving Global Outcomes\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003ePegEPO\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePegylated Erythropoetin\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDCGI\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDrug Controller General of India\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDOPPS\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDialysis Outcomes and Practice Patterns Study\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eNDD\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNon Dialysis Dependent\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eIV\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eIntravenous\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eSC\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eSubcutaneous\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eHD\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHemodialysis\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDA\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDarbepoetin Alfa\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDTP\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDose-titration period\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eEEP\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eEfficacy evaluation period\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eQOL\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eQuality of life\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003ePIVOTAL\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eProactive, High-Dose versus Reactive, Low-Dose Intravenous Iron Supplementation in Hemodialysis\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eCKD-MBD\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eChronic Kidney Disease Mineral Bone Disease\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eTSAT\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eTransferrin saturation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDD\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDialysis Dependent\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eHb\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHemoglobin\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eEPO\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eErythropoetin\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003erHuEPO\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRecombinant Human erythropoietin\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eDCR\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDose conversion ratio\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003eIU\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInternational units\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003e\u003cb\u003ePD\u003c/b\u003e\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePeritoneal Dialysis\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e \u003cp\u003eThe survey did not include patient data, just doctors\u0026rsquo; opinions, it was completely anonymous, and informed consent was implicit in the heading of the own survey\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent for publication:\u003c/strong\u003e \u003cp\u003eConsent was obtained from all authors for publication of this manuscript\u003c/p\u003e \u003c/p\u003e\u003cp\u003e \u003ch2\u003eCompeting interests:\u003c/h2\u003e \u003cp\u003eThe authors declare that they have no competing interests. Jay Kumar Sharma is an employee of Intas Pharmaceuticals and did not take part in formation of questionnaire or consensus statements.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding:\u003c/h2\u003e \u003cp\u003eThere was no funding for this research\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eVK, KK, JaK, MH contributed to conception and design of the article. JiK, SS, PK contributed to analysis of the data and formation of tables. SM, RB, RN, RS contributed to the interpretation of data and revision of the article. VS, SG, JS and IM contributed to analysis of the data and drafting of the article. All authors read and approved the final manuscript\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eOhashi N, Sakao Y, Yasuda H, Kato A, Fujigaki Y. Methoxy polyethylene glycol-epoetin beta for anemia with chronic kidney disease. Int J Nephrol Renovasc Dis. 2012;5:53\u0026ndash;60. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2147/IJNRD.S23447\u003c/span\u003e\u003cspan address=\"10.2147/IJNRD.S23447\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKim D, Lee J, Toyama T, Liyanage T, Woodward M, Matsushita K, et al. Asian Renal Collaboration. 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Cureus. 2025;17(9):e93584. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.7759/cureus.93584\u003c/span\u003e\u003cspan address=\"10.7759/cureus.93584\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Chronic Kidney Disease, Anemia, Pegylated erythropoietin","lastPublishedDoi":"10.21203/rs.3.rs-8706096/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8706096/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eAnemia is a common complication in chronic kidney disease (CKD) and is associated with adverse outcomes particularly in the advanced stage. Iron therapy and Erythropoesis stimulating agents (ESAs) form the cornerstone of its management. Among ESAs, there are various options available for usage, however each one differs in its structure and frequency of administration. Pegylated erythropoietin is having the longest half life, and is available for usage in renal anemia in India for long time but somewhat is less utilized in therapy. This consensus was done to generate expert consensus from practising Nephrologists from India regarding pegylated erythropoietin utility in CKD induced anemia\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eUsing a modified Delphi methodology, an expert panel underwent three rounds of survey and came up with the expert consensus. Responses were recorded using 5- point Likert scale.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA total of 35 consensus statements were generated, 12/35 (100%) had unanimous agreement, 9/35 had\u0026thinsp;\u0026gt;\u0026thinsp;90% agreement and rest of them were above the predefined threshold of \u0026gt;\u0026thinsp;75%.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003ePegylated erythropoietin, being the longest acting ESA has certain advantages like longer half life, lesser Hb fluctuations and lesser pricks, has shown to be non inferior to other ESAs in various phase 3 and real world studies. The consensus statement in this study will guide the nephrologists regarding usage of pegylated erythropoietin in renal anemia and its placement in the therapy.\u003c/p\u003e","manuscriptTitle":"Real World Use of Pegylated Erythropoietin in CKD Anemia: An Indian Modified Delphi Consensus","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-13 14:40:18","doi":"10.21203/rs.3.rs-8706096/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a0b970f1-6a0e-4094-81bc-0413965f8fb2","owner":[],"postedDate":"February 13th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-04-14T15:41:32+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-13 14:40:18","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8706096","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8706096","identity":"rs-8706096","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}