Efficacy and Safety of Sucroferric Oxyhydroxide compared with sevelamer in Chronic Kidney Disease Patients with Hyperphosphataemia- A Pilot Study  

Efficacy and Safety of Sucroferric Oxyhydroxide compared with sevelamer in Chronic Kidney Disease Patients with Hyperphosphataemia- A Pilot Study | 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 Efficacy and Safety of Sucroferric Oxyhydroxide compared with sevelamer in Chronic Kidney Disease Patients with Hyperphosphataemia- A Pilot Study Bennett Biju, Ian Osoro, Manoj Balaji, Sharan Thangaraji, MG Rajanandh, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8524035/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 Our study aimed to evaluate the efficacy and safety of Sucroferric oxyhydroxide (SFOH), an iron-based phosphate binder, compared to sevelamer, a non-calcium-based phosphate binder, in patients with CKD and hyperphosphatemia. Patients undergoing hemodialysis were selected based on their phosphate levels and other relevant parameters. A total of 64 patients were included and divided into two groups: sevelamer (n=32) and SFOH (n=32). Serum samples were collected at baseline and after 12 weeks. Medication adherence was assessed using the MARS-5 score. 64 patients were enrolled however only 60 patients completed the study (30 and 30 to SFOH and sevelamer respectively). In the SFOH group, the mean serum phosphate (sP) levels significantly decreased from baseline, while phosphate levels in the sevelamer group showed only a slight reduction i.e. 7.5±0.6 to 6.1±0.6 mg/dl and 7.6±0.6 to 6.5±0.5 mg/dl respectively. The reduction in serum phosphate was significantly greater in the SFOH group compared to the sevelamer group. This study demonstrates that SFOH effectively reduces serum phosphate levels, increases hemoglobin, and improves medication adherence compared to sevelamer. These findings support the use of SFOH as a beneficial phosphate binder in ESRD patients with hyperphosphatemia. SFOH medication adherence was 93.75% whereas sevelamer exhibited its adherence at 68.75% as per MARS-5 score. CKD mineral bone disease (MBD) hyperphosphatemia sevelamer sucroferric oxyhydroxide (SFOH) intact parathyroid hormone vascular calcification serum phosphorus(sP) Figures Figure 1 Summary at a Glance Hyperphosphatemia affects a significant portion of chronic kidney disease (CKD) patients and having the best medications enhances patient health outcomes. Our study evaluated the efficacy and safety of Sucroferric oxyhydroxide (SFOH), compared to sevelamer, in patients with CKD and hyperphosphatemia. SFOH was found to be more beneficial when compared to sevelamer and the results of our study underscore the importance of choosing medications with best outcomes for nephrology patients with chronic conditions. Introduction Hyperphosphatemia affects 25–30% of chronic kidney disease (CKD) patients, particularly in adults and the elderly 1 . Chronic kidney disease (CKD) is a complex, multifactorial, non-communicable disease with a significant global burden 2 . Phosphate binders are commonly used in managing hyperphosphatemia in end-stage renal disease (ESRD) patients. CKD-mineral and bone disorder (CKD-MBD), a common complication, is associated with hormonal imbalances and bone abnormalities, contributing to increased cardiovascular (CV) mortality, especially in dialysis patients 3 . Phosphate homeostasis plays a critical role in CKD-MBD progression and is independently linked to cardiovascular disease (CVD) 4 . As such, phosphate control is a key therapeutic target to mitigate vascular calcification, hyperparathyroidism, and hypocalcemia while reducing fibroblast growth factor 23 (FGF23) levels and ultimately lowering CV mortality risk 5 . Achieving optimal phosphate control, however, remains challenging. Most dialysis patients fail to reach target phosphate levels of < 5.5 mg/dL, with even fewer achieving the optimal level of < 4.5 mg/dL 5 . Phosphate binders are the primary pharmacological intervention for hyperphosphatemia, but their effectiveness is limited by the high pill burden, leading to poor adherence 3 . Sevelamer, a non-calcium-based, non-absorbable phosphate binder, is commonly used but requires multiple large pills per meal, contributing to non-compliance 6 . Sucroferric oxyhydroxide (SFOH), an iron-based phosphate binder, offers a promising alternative 7 . SFOH effectively reduces serum phosphate levels while also improving medication adherence due to its lower pill burden 8 . This reduced pill burden makes it more convenient for patients and has been shown to improve phosphate control, which is crucial in slowing CKD-MBD progression and reducing CV mortality risk 4 . In addition to phosphate control, SFOH has shown additional clinical benefits, including increased haemoglobin and serum iron levels and a reduction in intact parathyroid hormone (iPTH) levels in end-stage renal disease (ESRD) patients 4 . These benefits address both hyperphosphatemia and anaemia, which are common in CKD patients 9 . SFOH has been proven to be of great efficacy among populations from USA, Japan, EU and even China at a 1500mg/day starting dose. Notably, the Indian population significantly varies from the western based on factors such as dietary habits, social lifestyle and even medication usage. A high phosphorous intake was noted among Indian participants in a study by Rao et al [10]. Further, there is only one study that has been conducted in India comparing the safety and efficacy of SFOH and sevelamer according to the best of our knowledge. Thus, the aim of this study was to investigate the efficacy and safety of SFOH compared with sevelamer in Indian chronic kidney disease patients with hyperphosphataemia. Methods This study was designed as a prospective, observational study aimed at evaluating the efficacy of Sucroferric oxyhydroxide compared to sevelamer in reducing phosphate levels in CKD patients undergoing dialysis. Approval was obtained from the Institutional Review Board of SRM Medical College Hospital and Research Centre, and the study was conducted according to the guidelines of the Declaration of Helsinki. Written informed consent was obtained from all participants after explaining the study objectives, procedure, potential risks, and benefits before enrolment by the physician. We included patients undergoing stable hemodialysis as per unit protocol with adequate kt/v>3.6 for ≥ 12 weeks and who were planned to continue on the same hemodialysis schedule, and patients of both sexes older than 18 years with serum phosphorus level >5.5 mg/dl at screening. We excluded patients with intact parathyroid hormone level >800 ng/l or 88 pmol/l at time of screening, After initial evaluation by the physician during scheduled routine visits, participants were approached for possible enrolment based on inclusion and exclusion criteria. After successful selection, patients were divided into two groups depending on either of the two phosphate binders prescribed by the doctor. After collecting baseline data each patient was asked to come for a follow-up on the 12 th week. The patients in each group were also given a set of subjective tools to measure medical adherence, which was then assessed on follow-ups. Figure 1 shows a complete overview of how we conducted our study. Study procedure All participants underwent a detailed baseline assessment. This included measurement of haemoglobin, Transferrin saturation, serum electrolytes such as sodium, potassium, chloride, bicarbonates, calcium, phosphate and other parameters such as pre-creatinine and post-creatinine levels as an indicator of CKD. The iPTH levels and serum TSAT were checked at the baseline and on the 12 th week to check for the drug's effectiveness. In this study, sixty-four patients were enrolled, and they were divided into two groups (i.e group A and group B). Group A received sevelamer 800 mg QID and group B received Sucroferric oxyhydroxide 500mg TDS, having been separated by the physician. The same dose was maintained throughout the study duration for both SFOH and sevelamer. Study Variables Transferrin (TSAT): TSAT is an essential biomarker for assessing iron status and anaemia management in CKD. The blood sample was collected along with the routine blood collection in the Renal Dialysis Unit. TSAT helps differentiate true iron deficiency from functional iron deficiency. According to KDIGO guidelines, the target TSAT recommended for CKD patients were: >20% for TSAT and >100ng/ml for ferritin [11]. Intact Parathyroid Hormone(iPTH): In CKD, iPTH levels are the cornerstone for managing chronic kidney disease and mineral bone disorder. As kidney function declines, this disrupts mineral metabolism, ultimately leading to secondary hyperparathyroidism. iPTH is a dynamic marker requiring individualized targets based on CKD stage and complications. The sample was collected in an EDTA tube along with the routine blood tests. Outcome measures This study was designed to evaluate both objective and subjective outcomes to comprehensively assess the impact of SFOH compared to sevelamer. The primary outcome included changes in serum phosphate levels, measured at baseline and week 12. The secondary outcome focused on increasing the medication adherence by decreasing the pill burden compared to the sevelamer and assessing for medication safety through adverse events (AEs) or adverse drug reactions (ADRs). Statistical analysis Data were analyzed using SPSS version 26.0. Descriptive statistics were used to summarize demographic and baseline characteristics. Paired t-tests were conducted to evaluate within the group changes. The results were presented as mean ± standard deviation (Mean ±SD) for continuous variables. The Fisher Exact test or Chi-Square test was used for demographic variables expressed in numbers and percentages. The data was considered to have a significant difference at p<0.05. Results In our study, four patients dropped out due to inconvenience, resulting in a final sample of 60 (group A: n=30, group B: n=30). The average age of the sample population is 60 years, with a range from 52 to 69 years, indicating an older adult demographic. The gender breakdown shows a predominant male representation at 66.7%, highlighting a significant gender disparity as seen in table 1 below. Further, the most prevalent primary disease conditions were diabetes mellitus (43.3%) and hypertension (35%). Table 1. Patient demographic details and clinical measurements Parameter SFOH (n=30) Sevelamer (n=30) Total (n=60) Age (years) Mean 58.5±11.1 62.2±6.8 60.4± 8.5 Sex, n (%) Male Female 21 (70) 9 (30) 19 (63.3) 11 (36.7) 40 (66.7) 20 (33.3) Baseline height (cm) Mean ±SD 164.2±6.1 165.6±5.6 163.7±8.9 Baseline weight (kg) Mean ±SD 68.0±13.4 71.3±8.9 69.4±11.2 Baseline BMI Mean ±SD 23.3±6.2 26.5±4.1 24.2±3.4 Duration from CKD diagnosis to enrollment, n Mean ±SD 5.4±4.0 5.7±3.6 6.1±2.8 Dialysis type, n (%) HD 30 (100) 30 (100) 60 (100) Primary reason for CKD n (%) Hypertension Diabetes mellitus Other 7 (23.3) 16 (53.4) 7 (23.3) 14 (46.7) 10 (33.3) 6 (20.0) 21 (35) 26 (43.3) 13 (21.7) Abbreviations; CKD ( chronic kidney disease) , SFOH ( Sucroferric oxyhydroxid e) Parameters such as serum calcium, serum phosphorus, iPTH, and TSAT were observed and used to assess the effectiveness of SFOH on phosphorus levels, as well as the MARS score was recorded. These parameters were observed at baseline and the 12 th week as seen in table 2 below. Table 2. Comparison of the laboratory parameters with p value Parameters Baseline 12 weeks P value Group A Group B Group A Group B Sodium 135±2.7 135±3.1 138±2.9 138±3.1 0.074 Potassium 6.1±0.8 6.2±0.7 6.8±0.7 6.9±0.7 0.023 Calcium 8.4±0.5 8.0±0.6 9.1±0.5 9.7±0.5 0.31 TSAT 26.2±4.5 28.3±5.0 28.0±4.7 29.2±5.3 0.14 Hemoglobin 11.2±1.2 10.9±1.2 12.9±1.3 11.6±1.3 0.15 i-PTH 113±45.8 112±41.9 120.6±25.3 119.9±22.5 0.28 Serum phosphate 7.6±0.6 7.5±0.6 6.5±0.5 6.4±0.6 0.001 * * =significant value, Abbreviations: Transferrin (TSAT), Intact Parathyroid Hormone(iPTH) Overall, serum phosphate experienced a significant decrease after 12 weeks of treatment on SFOH from 7.5±0.6 to 6.4±0.6 mg/dl respectively ( P<0.001). The mean decrease was at 14.67%. Throughout the study, no significant changes were observed in serum levels of calcium, iPTH, TSAT and haemoglobin although an increasing trend was observed in the Hb and TSAT parameters. Assessment of safety and medication adherence Throughout the study period, no was observed in the SFOH group, confirming its safety in our study population. On evaluation of MARS 5 score, it was noted that SFOH had a better medication adherence outcome in comparison to sevelamer (for patients consuming SFOH was 93.75%, which was good, whereas sevelamer exhibited at 68.75%). Discussion This study was conducted to evaluate the safety and efficacy of sucroferric oxyhydroxide in chronic kidney disease patients with hyperphosphatemia. The parameters used for examining the efficacy of SFOH were sP at baseline and end of 12 weeks compared to the traditional treatment, i.e., sevelamer. Medication adherence was recorded using a MARS-5 scale. In this study, it was observed that levels of sP were reduced and maintained at considerably earlier time points in group B than in group A. Sucroferric oxyhydroxide binds with phosphate far more effectively in patients than sevelamer does in patients. SFOH had a lower pill burden compared to sevelamer which helps in improving medication adherence among patients. The low pill burden is important as those undergoing dialysis find it easier to consume the tablets, which are also chewable. The normal dose of sevelamer is 400mg twice daily, which increases the pill burden. A higher pill burden will contribute to non-adherence, which can be seen in the case of sevelamer 10 . Sucroferric oxyhydroxide is an effective phosphate binder for treating hyperphosphatemia in chronic kidney disease patients, including those on hemodialysis and peritoneal dialysis 7 , 11 , 12 . Studies have shown that SFOH significantly reduces serum phosphate levels and fibroblast growth factor 23 (FGF23) 11 , 13 . Additionally, SFOH treatment has been associated with improvements in renal anaemia, increasing haemoglobin levels and reducing the need for erythropoiesis-stimulating agents and intravenous iron. Some studies have reported increased ferritin levels and transferrin saturation with SFOH use 13 . SFOH has also been shown to increase soluble Klotho levels and decrease C-reactive protein levels 14 – 16 . Sucroferric oxyhydroxide (PA21) is an effective iron-based phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis. Studies have shown that PA21 significantly reduces serum phosphorus levels and is as effective as other phosphate binders in controlling hyperphosphatemia and secondary hyperparathyroidism 11 , 17 . PA21 has also been associated with decreased fibroblast growth factor 23 (FGF23) levels, improved renal anaemia, and reduced vascular calcifications 11 , 17 . Notably, SFOH treatment has been linked to a significant reduction in intact parathyroid hormone (iPTH) levels without altering vitamin D or calcimimetic supplementation 18 . The medication is well-tolerated, with a low pill burden that may improve treatment adherence 19 . PA21's favourable impact on mineral bone disease parameters and low systemic iron absorption make it an attractive non-calcium phosphate binder option for dialysis patients. SFOH and sevelamer carbonate are equally effective in controlling serum phosphorus levels in dialysis patients 19 , 20 . However, SFOH demonstrates a more favorable gastrointestinal adverse event profile and a significantly lower pill burden compared to sevelamer 19 . This reduced pill burden may contribute to better treatment adherence, with one study reporting 91.2% adherence for SFOH versus 79.3% for sevelamer in peritoneal dialysis patients 21 . SFOH is well-tolerated and associated with low systemic iron absorption, minimizing potential iron accumulation. While both SFOH and ferric citrate hydrate show similar efficacy and safety to sevelamer, head-to-head studies with lanthanum carbonate are lacking 22 . Long-term studies are needed to confirm the potential advantages of SFOH in terms of improved adherence and cost-effectiveness. Furthermore, this drug showed no side effects at any point, indicating the normal safety profile of SFOH 22 . In our study, medication adherence for patients consuming SFOH was 93.75%, which was good, whereas sevelamer exhibited non-adherence at 68.75% which was recorded using a MARS-5 scale. Limitations : The study needs to be done in a large population, as the same dialysis patients were repeated during the study. Further, a prolonged duration of time can be used in observing the outcomes from both groups involved in our study in order to assess for long term efficacy and cost economic implications of both drugs. Conclusion From this study, we can see that SFOH reduced serum phosphate levels from baseline to 12 weeks at a faster rate, and it was non-inferior to sevelamer. Further, it was found that SFOH had better medication adherence than the conventional treatment which can be attributed to the lower pill burden. The results of this study strengthen the efficacy and safety of SFOH. Declarations Transparency: Funding and affiliation: Department of Pharmacy Practice, SRM School of Pharmacy, SRM Medical College and Research Centre, Faculty of Medicine Conflict of Interest The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Author contributions Conceptualisation, B. B.K.; I.O.; and M.G.R.; Methodology, V.M.B.; I.O.; S.V.T.; validation V.I.; I.O.; S.I. and M.G.R; writing review and editing, I.O.; B. B.K.; S.V.T; and M.G.R. All authors have read and agreed to the published version of the manuscript. Ethics Statement & Informed Consent The study was conducted in accordance with the Declaration of Helsinki. All participants in our study gave their informed consent in order to participate. Further, approval was obtained from the Institutional Review Board of SRM Medical College Hospital and Research Centre (SRMIEC-ST0123-788). Data Availability Statement The data used for the evaluation of this study have been presented in the manuscript. Further inquiries should be directed to the corresponding author. References Cernaro, V., Longhitano, E., Casuscelli, C., Peritore, L. & Santoro, D. Hyperphosphatemia in Chronic Kidney Disease: The Search for New Treatment Paradigms and the Role of Tenapanor. Int J Nephrol Renovasc Dis 17, 151–161 (2024). Shaman, A. M. & Kowalski, S. R. Hyperphosphatemia Management in Patients with Chronic Kidney Disease. Saudi Pharm J 24, 494–505 (2016). Chan, S. et al. Phosphate binders in patients with chronic kidney disease. Aust Prescr 40, 9–14 (2017). Ruospo, M. et al. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev 8, (2018). Floege, J. et al. Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrol Dial Transplant 30, 1037–1046 (2015). Marando, M., Tamburello, A., Salera, D., Di Lullo, L. & Bellasi, A. Phosphorous metabolism and manipulation in chronic kidney disease. Nephrology 29, 791–800 (2024). Sanchez-Alvarez, J. E. et al. Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease. FOSFASTUR study. Nefrologia 41, 45–52 (2021). Kalantar-Zadeh, K. et al. Real-World Scenario Improvements in Serum Phosphorus Levels and Pill Burden in Peritoneal Dialysis Patients Treated with Sucroferric Oxyhydroxide. Am J Nephrol 47, 153–161 (2018). Block, G. & Port, F. K. Calcium phosphate metabolism and cardiovascular disease in patients with chronic kidney disease. Semin Dial 16, 140–147 (2003). Liu, J. et al. Efficacy and Safety of Sucroferric Oxyhydroxide Compared with Sevelamer Carbonate in Chinese Dialysis Patients with Hyperphosphataemia: A Randomised, Open-Label, Multicentre, 12-Week Phase III Study. Nephron 148, 22–33 (2024). Shima, H., Miya, K., Okada, K., Minakuchi, J. & Kawashima, S. Sucroferric oxyhydroxide decreases serum phosphorus level and fibroblast growth factor 23 and improves renal anemia in hemodialysis patients. BMC Res Notes 11, 1–8 (2018). Teo, R. Z. C. et al. Sucroferric oxyhydroxide use in patients on haemodialysis – real-world experience from an Asian cohort. Proceedings of Singapore Healthcare 32, (2023). Bouquegneau, A. et al. MO543: Efficacy and Influence on the Key Indicators of Mineral-Bone Disorders of the Sucroferric Oxyhydroxide and Sevelamer Carbonate in Hemodialysis Patients. Nephrology Dialysis Transplantation 37, (2022). Covic, A. C. et al. Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. Nephrology Dialysis Transplantation 32, 1330–1338 (2017). Liu, J. et al. Efficacy and Safety of Sucroferric Oxyhydroxide Compared with Sevelamer Carbonate in Chinese Dialysis Patients with Hyperphosphataemia: A Randomised, Open-Label, Multicentre, 12-Week Phase III Study. Nephron 148, 22–33 (2024). Covic, A. C. et al. Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. Nephrol Dial Transplant 32, 1363–1372 (2017). Phan, O. et al. Effects of Sucroferric Oxyhydroxide Compared to Lanthanum Carbonate and Sevelamer Carbonate on Phosphate Homeostasis and Vascular Calcifications in a Rat Model of Chronic Kidney Failure. Biomed Res Int 2015, 515606 (2015). I, G., P, S., C, A. & M, A. Sucroferric oxyhydroxide: A novel phosphate binder for the management of mineral bone disease in dialysis patients. Blood, Heart and Circulation 3, (2019). Sprague, S. M. & Floege, J. Sucroferric oxyhydroxide for the treatment of hyperphosphatemia. Expert Opin Pharmacother 19, 1137–1148 (2018). Georgopoulos, C. et al. #2028 Efficacy and safety of sucroferric oxyhydroxide versus sevelamer carbonate: a systematic review and meta-analysis. Nephrology Dialysis Transplantation 39, (2024). Covic, A. C. et al. Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. Nephrology Dialysis Transplantation 32, 1330–1338 (2017). Schmid, H. & Lederer, S. R. Novel iron-containing phosphate binders for treatment of hyperphosphatemia. Expert Opin Pharmacother 16, 2179–2191 (2015). Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8524035","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":583344318,"identity":"fb0f14f1-2873-402e-9cd3-d27ec40cdfd3","order_by":0,"name":"Bennett Biju","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Bennett","middleName":"","lastName":"Biju","suffix":""},{"id":583344322,"identity":"53d5531d-43e2-4fd4-b03f-f5f9a54580e8","order_by":1,"name":"Ian Osoro","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Ian","middleName":"","lastName":"Osoro","suffix":""},{"id":583344323,"identity":"b8c49d47-2060-4b2e-b126-a2be52086da8","order_by":2,"name":"Manoj Balaji","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Manoj","middleName":"","lastName":"Balaji","suffix":""},{"id":583344324,"identity":"9e838b64-d990-489a-a769-67b8491be148","order_by":3,"name":"Sharan Thangaraji","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Sharan","middleName":"","lastName":"Thangaraji","suffix":""},{"id":583344332,"identity":"5acbf68b-fab3-4541-a525-9582cb08272c","order_by":4,"name":"MG Rajanandh","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAvklEQVRIiWNgGAWjYHACxgdAggfM5IExCABmA7BiNhK0sElAKAYi1ev2r31W+XPPNhn5+Q2MD962MciYE9JiduO52W2eZ7d5DI4xMBvObWPgsWwgqOUY222GA0AtbAxs0rxALQYHiNBS+AOoRb6Ngf03cVrOt7Ex8AC1MBxjYGMm0hY2ZmmQFoNjic2Sc85JEGPLMcaPQIfZyzcfPvjhTZmNPUEtDBIJMBZjA4hLSD0Q8BM0dBSMglEwCkY8AACW1TtkEPy7/AAAAABJRU5ErkJggg==","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":true,"prefix":"","firstName":"MG","middleName":"","lastName":"Rajanandh","suffix":""},{"id":583344339,"identity":"982b7656-4613-4e87-8390-15bec47a8ddb","order_by":5,"name":"S Ilango","email":"","orcid":"","institution":"SRM Institute of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"S","middleName":"","lastName":"Ilango","suffix":""}],"badges":[],"createdAt":"2026-01-05 18:08:43","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8524035/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8524035/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":101639038,"identity":"45030ff5-89b3-429b-ad12-e4c9891889f8","added_by":"auto","created_at":"2026-02-02 07:16:45","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":29453,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eStudy flowchart\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSTROBE Diagram\u003c/em\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8524035/v1/4419df5d00c2f9a91e8631a0.png"},{"id":103988522,"identity":"72f22668-60a4-4f4f-b985-64b6a21d71d7","added_by":"auto","created_at":"2026-03-05 10:57:23","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":555690,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8524035/v1/fc19d298-677b-4790-84d4-5a13daf7ff0f.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy and Safety of Sucroferric Oxyhydroxide compared with sevelamer in Chronic Kidney Disease Patients with Hyperphosphataemia- A Pilot Study ","fulltext":[{"header":"Summary at a Glance ","content":"\u003cp\u003eHyperphosphatemia affects a significant portion of chronic kidney disease (CKD) patients and having the best medications enhances patient health outcomes. Our study evaluated the efficacy and safety of Sucroferric oxyhydroxide (SFOH), compared to sevelamer, in patients with CKD and hyperphosphatemia. SFOH was found to be more beneficial when compared to sevelamer and the results of our study underscore the importance of choosing medications with best outcomes for nephrology patients with chronic conditions.\u003c/p\u003e"},{"header":"Introduction","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eHyperphosphatemia affects 25\u0026ndash;30% of chronic kidney disease (CKD) patients, particularly in adults and the elderly\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e. Chronic kidney disease (CKD) is a complex, multifactorial, non-communicable disease with a significant global burden\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. Phosphate binders are commonly used in managing hyperphosphatemia in end-stage renal disease (ESRD) patients. CKD-mineral and bone disorder (CKD-MBD), a common complication, is associated with hormonal imbalances and bone abnormalities, contributing to increased cardiovascular (CV) mortality, especially in dialysis patients\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003ePhosphate homeostasis plays a critical role in CKD-MBD progression and is independently linked to cardiovascular disease (CVD) \u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. As such, phosphate control is a key therapeutic target to mitigate vascular calcification, hyperparathyroidism, and hypocalcemia while reducing fibroblast growth factor 23 (FGF23) levels and ultimately lowering CV mortality risk\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e. Achieving optimal phosphate control, however, remains challenging. Most dialysis patients fail to reach target phosphate levels of \u0026lt;\u0026thinsp;5.5 mg/dL, with even fewer achieving the optimal level of \u0026lt;\u0026thinsp;4.5 mg/dL\u003csup\u003e5\u003c/sup\u003e. Phosphate binders are the primary pharmacological intervention for hyperphosphatemia, but their effectiveness is limited by the high pill burden, leading to poor adherence\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e. Sevelamer, a non-calcium-based, non-absorbable phosphate binder, is commonly used but requires multiple large pills per meal, contributing to non-compliance\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eSucroferric oxyhydroxide (SFOH), an iron-based phosphate binder, offers a promising alternative\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. SFOH effectively reduces serum phosphate levels while also improving medication adherence due to its lower pill burden\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e. This reduced pill burden makes it more convenient for patients and has been shown to improve phosphate control, which is crucial in slowing CKD-MBD progression and reducing CV mortality risk\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. In addition to phosphate control, SFOH has shown additional clinical benefits, including increased haemoglobin and serum iron levels and a reduction in intact parathyroid hormone (iPTH) levels in end-stage renal disease (ESRD) patients\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. These benefits address both hyperphosphatemia and anaemia, which are common in CKD patients\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eSFOH has been proven to be of great efficacy among populations from USA, Japan, EU and even China at a 1500mg/day starting dose. Notably, the Indian population significantly varies from the western based on factors such as dietary habits, social lifestyle and even medication usage. A high phosphorous intake was noted among Indian participants in a study by Rao \u003cem\u003eet al\u003c/em\u003e [10]. Further, there is only one study that has been conducted in India comparing the safety and efficacy of SFOH and sevelamer according to the best of our knowledge. Thus, the aim of this study was to investigate the efficacy and safety of SFOH compared with sevelamer in Indian chronic kidney disease patients with hyperphosphataemia.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThis study was designed as a prospective, observational study aimed at evaluating the efficacy of Sucroferric oxyhydroxide compared to sevelamer in reducing phosphate levels in CKD patients undergoing dialysis. Approval was obtained from the Institutional Review Board of SRM Medical College Hospital and Research Centre, and the study was conducted according to the guidelines of the Declaration of Helsinki. Written informed consent was obtained from all participants after explaining the study objectives, procedure, potential risks, and benefits before enrolment by the physician. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe included patients undergoing stable hemodialysis as per unit protocol with adequate kt/v\u0026gt;3.6 for\u0026nbsp;\u0026ge; 12 weeks and who were planned to continue on\u0026nbsp;the same hemodialysis schedule,\u0026nbsp;and\u0026nbsp;patients of both\u0026nbsp;sexes\u0026nbsp;older\u0026nbsp;than 18\u0026nbsp;years\u0026nbsp;with\u0026nbsp;serum\u0026nbsp;phosphorus\u0026nbsp;level\u0026nbsp;\u0026gt;5.5\u0026nbsp;mg/dl\u0026nbsp;at\u0026nbsp;screening.\u0026nbsp;We excluded patients\u0026nbsp;with\u0026nbsp;intact\u0026nbsp;parathyroid\u0026nbsp;hormone\u0026nbsp;level\u0026nbsp;\u0026gt;800\u0026nbsp;ng/l\u0026nbsp;or\u0026nbsp;88 pmol/l at time of screening, \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAfter initial evaluation by the physician during scheduled routine visits, participants were approached for possible enrolment based on inclusion and exclusion criteria. After successful selection, patients were divided into two\u0026nbsp;groups depending on either of the two\u0026nbsp;phosphate binders prescribed by the doctor. After collecting baseline data each patient was asked to come for a follow-up on the 12\u003csup\u003eth\u003c/sup\u003e week. The patients in each group were also given a set of subjective tools to measure medical adherence, which was then assessed on follow-ups. \u003cem\u003eFigure 1\u003c/em\u003e shows a complete overview of how we conducted our study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy procedure\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll participants underwent a detailed baseline assessment. This included measurement of haemoglobin, Transferrin saturation, serum electrolytes such as sodium, potassium, chloride, bicarbonates, calcium, phosphate and other parameters such as pre-creatinine and post-creatinine levels as an indicator of CKD. The\u0026nbsp;iPTH\u0026nbsp;levels\u0026nbsp;and\u0026nbsp;serum\u0026nbsp;TSAT\u0026nbsp;were\u0026nbsp;checked\u0026nbsp;at\u0026nbsp;the\u0026nbsp;baseline\u0026nbsp;and\u0026nbsp;on\u0026nbsp;the\u0026nbsp;12\u003csup\u003eth\u003c/sup\u003e week to check for the drug\u0026apos;s effectiveness.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn this study, sixty-four patients were enrolled, and they were divided into two groups (i.e group A and group B). Group A received sevelamer 800 mg QID and group B received Sucroferric oxyhydroxide 500mg TDS, having been separated by the physician. The same dose was maintained throughout the study duration for both SFOH and sevelamer.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy Variables\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTransferrin\u003c/em\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003cem\u003e(TSAT):\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTSAT\u0026nbsp;is\u0026nbsp;an\u0026nbsp;essential\u0026nbsp;biomarker\u0026nbsp;for\u0026nbsp;assessing\u0026nbsp;iron\u0026nbsp;status\u0026nbsp;and\u0026nbsp;anaemia\u0026nbsp;management in\u0026nbsp;CKD.\u0026nbsp;The\u0026nbsp;blood\u0026nbsp;sample\u0026nbsp;was\u0026nbsp;collected\u0026nbsp;along\u0026nbsp;with\u0026nbsp;the\u0026nbsp;routine\u0026nbsp;blood\u0026nbsp;collection\u0026nbsp;in the Renal Dialysis Unit. TSAT helps differentiate true iron deficiency from functional iron\u0026nbsp;deficiency.\u0026nbsp;According\u0026nbsp;to\u0026nbsp;KDIGO\u0026nbsp;guidelines,\u0026nbsp;the\u0026nbsp;target\u0026nbsp;TSAT\u0026nbsp;recommended\u0026nbsp;for CKD patients were: \u0026gt;20% for TSAT and \u0026gt;100ng/ml for ferritin [11].\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eIntact\u0026nbsp;Parathyroid Hormone(iPTH):\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn CKD, iPTH levels are the cornerstone for managing chronic kidney disease and mineral bone disorder. As kidney function declines, this disrupts mineral metabolism, ultimately leading to secondary hyperparathyroidism. iPTH is a dynamic marker requiring individualized targets based on CKD stage and complications. The sample was collected in an EDTA tube along with the routine blood tests.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eOutcome measures\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis study was designed to evaluate both objective and subjective outcomes to comprehensively assess the impact of SFOH compared to sevelamer. The primary outcome included changes in serum phosphate levels, measured at baseline and week 12. The secondary outcome focused on increasing the medication adherence by decreasing the pill burden compared to the sevelamer and assessing for medication safety through\u0026nbsp;adverse events (AEs) or adverse drug reactions (ADRs).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStatistical analysis\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eData were analyzed using SPSS version 26.0. Descriptive statistics were used to summarize demographic and baseline characteristics. Paired t-tests were conducted to evaluate within the group changes.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eThe results were presented as mean \u0026plusmn; standard deviation (Mean \u0026plusmn;SD) for continuous variables. The Fisher Exact test or Chi-Square test was used for demographic variables expressed in numbers and percentages. The data was considered to have a significant difference at p\u0026lt;0.05.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eIn our study, four patients dropped out due to inconvenience, resulting in a final sample of 60 (group A: n=30, group B: n=30). The average age of the sample population is 60 years, with a range from 52 to 69 years, indicating an older adult demographic. The gender breakdown shows a predominant male representation at 66.7%, highlighting a significant gender disparity as seen in \u003cem\u003etable 1\u003c/em\u003e below. Further, the most prevalent primary disease conditions were diabetes mellitus (43.3%) and hypertension (35%).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 1. \u003cem\u003ePatient demographic details and clinical measurements\u003c/em\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"656\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eParameter\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSFOH (n=30)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSevelamer (n=30)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTotal (n=60)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003eAge (years)\u003c/p\u003e\n \u003cp\u003eMean\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e58.5\u0026plusmn;11.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e62.2\u0026plusmn;6.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e60.4\u0026plusmn; 8.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003eSex, \u003cem\u003en (%)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eMale\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eFemale\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;21 (70)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;9 (30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e19 (63.3)\u003c/p\u003e\n \u003cp\u003e11 (36.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e40 (66.7)\u003c/p\u003e\n \u003cp\u003e20 (33.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003eBaseline height (cm)\u003c/p\u003e\n \u003cp\u003eMean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e164.2\u0026plusmn;6.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e165.6\u0026plusmn;5.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e163.7\u0026plusmn;8.9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003eBaseline weight (kg)\u003c/p\u003e\n \u003cp\u003eMean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e68.0\u0026plusmn;13.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e71.3\u0026plusmn;8.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e69.4\u0026plusmn;11.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003eBaseline BMI\u003c/p\u003e\n \u003cp\u003eMean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e23.3\u0026plusmn;6.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e26.5\u0026plusmn;4.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e24.2\u0026plusmn;3.4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003eDuration from CKD diagnosis to enrollment, \u003cem\u003en\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eMean \u0026plusmn;SD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5.4\u0026plusmn;4.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5.7\u0026plusmn;3.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e6.1\u0026plusmn;2.8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003eDialysis type, \u003cem\u003en (%)\u003c/em\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eHD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e30 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e30 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e60 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 196px;\"\u003e\n \u003cp\u003ePrimary reason for CKD\u003cem\u003e\u0026nbsp;n (%)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eHypertension\u003c/p\u003e\n \u003cp\u003eDiabetes mellitus\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eOther\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e7 (23.3)\u003c/p\u003e\n \u003cp\u003e16 (53.4)\u003c/p\u003e\n \u003cp\u003e7 (23.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e14 (46.7)\u003c/p\u003e\n \u003cp\u003e10 (33.3)\u003c/p\u003e\n \u003cp\u003e6 (20.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e21 (35)\u003c/p\u003e\n \u003cp\u003e26 (43.3)\u003c/p\u003e\n \u003cp\u003e13 (21.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003cem\u003eAbbreviations; CKD (\u003c/em\u003e\u003cem\u003echronic kidney disease)\u003c/em\u003e\u003cem\u003e, SFOH (\u003c/em\u003e\u003cem\u003eSucroferric oxyhydroxid\u003c/em\u003ee)\u003c/p\u003e\n\u003cp\u003eParameters such as serum calcium, serum phosphorus, iPTH, and TSAT were observed\u0026nbsp;and\u0026nbsp;used\u0026nbsp;to\u0026nbsp;assess\u0026nbsp;the\u0026nbsp;effectiveness\u0026nbsp;of\u0026nbsp;SFOH\u0026nbsp;on\u0026nbsp;phosphorus\u0026nbsp;levels,\u0026nbsp;as well\u0026nbsp;as the\u0026nbsp;MARS\u0026nbsp;score\u0026nbsp;was\u0026nbsp;recorded.\u0026nbsp;These\u0026nbsp;parameters\u0026nbsp;were\u0026nbsp;observed\u0026nbsp;at baseline and the 12\u003csup\u003eth\u003c/sup\u003e week as seen in \u003cem\u003etable 2\u003c/em\u003e below.\u003c/p\u003e\n\u003cp\u003eTable 2. \u003cem\u003eComparison of the laboratory parameters with p value\u003c/em\u003e\u003c/p\u003e\n\u003cdiv align=\"center\"\u003e\n \u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"693\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"bottom\" style=\"width: 151px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;Parameters\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 224px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eBaseline\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"bottom\" style=\"width: 218px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e12 weeks\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"bottom\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eP value\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 113px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup A\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 110px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup B\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup A\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 111px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eGroup B\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 151px;\"\u003e\n \u003cp\u003eSodium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 113px;\"\u003e\n \u003cp\u003e135\u0026plusmn;2.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 110px;\"\u003e\n \u003cp\u003e135\u0026plusmn;3.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 107px;\"\u003e\n \u003cp\u003e138\u0026plusmn;2.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 111px;\"\u003e\n \u003cp\u003e138\u0026plusmn;3.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.074\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 151px;\"\u003e\n \u003cp\u003ePotassium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 113px;\"\u003e\n \u003cp\u003e6.1\u0026plusmn;0.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 110px;\"\u003e\n \u003cp\u003e6.2\u0026plusmn;0.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 107px;\"\u003e\n \u003cp\u003e6.8\u0026plusmn;0.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 111px;\"\u003e\n \u003cp\u003e6.9\u0026plusmn;0.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.023\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 151px;\"\u003e\n \u003cp\u003eCalcium\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 113px;\"\u003e\n \u003cp\u003e8.4\u0026plusmn;0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 110px;\"\u003e\n \u003cp\u003e8.0\u0026plusmn;0.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 107px;\"\u003e\n \u003cp\u003e9.1\u0026plusmn;0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 111px;\"\u003e\n \u003cp\u003e9.7\u0026plusmn;0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.31\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 151px;\"\u003e\n \u003cp\u003eTSAT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 113px;\"\u003e\n \u003cp\u003e26.2\u0026plusmn;4.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 110px;\"\u003e\n \u003cp\u003e28.3\u0026plusmn;5.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 107px;\"\u003e\n \u003cp\u003e28.0\u0026plusmn;4.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 111px;\"\u003e\n \u003cp\u003e29.2\u0026plusmn;5.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.14\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 151px;\"\u003e\n \u003cp\u003eHemoglobin\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 113px;\"\u003e\n \u003cp\u003e11.2\u0026plusmn;1.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 110px;\"\u003e\n \u003cp\u003e10.9\u0026plusmn;1.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 107px;\"\u003e\n \u003cp\u003e12.9\u0026plusmn;1.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 111px;\"\u003e\n \u003cp\u003e11.6\u0026plusmn;1.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.15\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 151px;\"\u003e\n \u003cp\u003ei-PTH\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 113px;\"\u003e\n \u003cp\u003e113\u0026plusmn;45.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 110px;\"\u003e\n \u003cp\u003e112\u0026plusmn;41.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 107px;\"\u003e\n \u003cp\u003e120.6\u0026plusmn;25.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 111px;\"\u003e\n \u003cp\u003e119.9\u0026plusmn;22.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.28\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"bottom\" style=\"width: 151px;\"\u003e\n \u003cp\u003eSerum phosphate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 113px;\"\u003e\n \u003cp\u003e7.6\u0026plusmn;0.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 110px;\"\u003e\n \u003cp\u003e7.5\u0026plusmn;0.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 107px;\"\u003e\n \u003cp\u003e6.5\u0026plusmn;0.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 111px;\"\u003e\n \u003cp\u003e6.4\u0026plusmn;0.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"bottom\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.001\u003csup\u003e*\u003c/sup\u003e\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cem\u003e\u003csup\u003e*\u003c/sup\u003e\u003c/em\u003e\u003cem\u003e=significant value, Abbreviations: Transferrin (TSAT), Intact Parathyroid Hormone(iPTH)\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOverall, serum phosphate experienced a significant decrease after 12 weeks of treatment on SFOH from 7.5\u0026plusmn;0.6 to 6.4\u0026plusmn;0.6 mg/dl respectively (\u003cem\u003eP\u0026lt;0.001).\u003c/em\u003e The mean decrease was at 14.67%. Throughout the study, no significant changes were observed in serum levels of calcium, iPTH, TSAT and haemoglobin although an increasing trend was observed in the Hb and TSAT parameters.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAssessment of safety and medication adherence \u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThroughout the study period, no was observed in the SFOH group, confirming its safety in our study population. On evaluation of MARS 5 score, it was noted that SFOH had a better medication adherence outcome in comparison to sevelamer (for patients consuming SFOH was 93.75%, which was good, whereas sevelamer exhibited at 68.75%).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThis study was conducted to evaluate the safety and efficacy of sucroferric oxyhydroxide in chronic kidney disease patients with hyperphosphatemia. The parameters used for examining the efficacy of SFOH were sP at baseline and end of 12 weeks compared to the traditional treatment, i.e., sevelamer. Medication adherence was recorded using a MARS-5 scale. In this study, it was observed that levels of sP were reduced and maintained at considerably earlier time points in group B than in group A. Sucroferric oxyhydroxide binds with phosphate far more effectively in patients than sevelamer does in patients.\u003c/p\u003e \u003cp\u003eSFOH had a lower pill burden compared to sevelamer which helps in improving medication adherence among patients. The low pill burden is important as those undergoing dialysis find it easier to consume the tablets, which are also chewable. The normal dose of sevelamer is 400mg twice daily, which increases the pill burden. A higher pill burden will contribute to non-adherence, which can be seen in the case of sevelamer\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e. Sucroferric oxyhydroxide is an effective phosphate binder for treating hyperphosphatemia in chronic kidney disease patients, including those on hemodialysis and peritoneal dialysis\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e,\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. Studies have shown that SFOH significantly reduces serum phosphate levels and fibroblast growth factor 23 (FGF23)\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. Additionally, SFOH treatment has been associated with improvements in renal anaemia, increasing haemoglobin levels and reducing the need for erythropoiesis-stimulating agents and intravenous iron. Some studies have reported increased ferritin levels and transferrin saturation with SFOH use\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e. SFOH has also been shown to increase soluble Klotho levels and decrease C-reactive protein levels\u003csup\u003e\u003cspan additionalcitationids=\"CR15\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eSucroferric oxyhydroxide (PA21) is an effective iron-based phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis. Studies have shown that PA21 significantly reduces serum phosphorus levels and is as effective as other phosphate binders in controlling hyperphosphatemia and secondary hyperparathyroidism\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e,\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. PA21 has also been associated with decreased fibroblast growth factor 23 (FGF23) levels, improved renal anaemia, and reduced vascular calcifications\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e,\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u003c/sup\u003e. Notably, SFOH treatment has been linked to a significant reduction in intact parathyroid hormone (iPTH) levels without altering vitamin D or calcimimetic supplementation\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. The medication is well-tolerated, with a low pill burden that may improve treatment adherence\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. PA21's favourable impact on mineral bone disease parameters and low systemic iron absorption make it an attractive non-calcium phosphate binder option for dialysis patients. SFOH and sevelamer carbonate are equally effective in controlling serum phosphorus levels in dialysis patients\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e,\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u003c/sup\u003e. However, SFOH demonstrates a more favorable gastrointestinal adverse event profile and a significantly lower pill burden compared to sevelamer\u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. This reduced pill burden may contribute to better treatment adherence, with one study reporting 91.2% adherence for SFOH versus 79.3% for sevelamer in peritoneal dialysis patients \u003csup\u003e\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e. SFOH is well-tolerated and associated with low systemic iron absorption, minimizing potential iron accumulation. While both SFOH and ferric citrate hydrate show similar efficacy and safety to sevelamer, head-to-head studies with lanthanum carbonate are lacking\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e. Long-term studies are needed to confirm the potential advantages of SFOH in terms of improved adherence and cost-effectiveness.\u003c/p\u003e \u003cp\u003eFurthermore, this drug showed no side effects at any point, indicating the normal safety profile of SFOH\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e. In our study, medication adherence for patients consuming SFOH was 93.75%, which was good, whereas sevelamer exhibited non-adherence at 68.75% which was recorded using a MARS-5 scale.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003e\u003cb\u003eLimitations\u003c/b\u003e:\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThe study needs to be done in a large population, as the same dialysis patients were repeated during the study. Further, a prolonged duration of time can be used in observing the outcomes from both groups involved in our study in order to assess for long term efficacy and cost economic implications of both drugs.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eFrom this study, we can see that SFOH reduced serum phosphate levels from baseline to 12 weeks at a faster rate, and it was non-inferior to sevelamer. Further, it was found that SFOH had better medication adherence than the conventional treatment which can be attributed to the lower pill burden. The results of this study strengthen the efficacy and safety of SFOH.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eTransparency:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding and affiliation:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDepartment of Pharmacy Practice, SRM School of Pharmacy, SRM Medical College and Research Centre, Faculty of Medicine\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of Interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualisation, B. B.K.; I.O.; and M.G.R.; Methodology, V.M.B.; I.O.; S.V.T.; validation V.I.; I.O.; S.I. and M.G.R; writing review and editing, I.O.; B. B.K.; S.V.T; and M.G.R. All authors have read and agreed to the published version of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics Statement \u0026amp; Informed Consent\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was conducted in accordance with the Declaration of \u0026nbsp;Helsinki. All participants in our study gave their informed consent in order to participate. Further, approval was obtained from the Institutional Review Board of SRM Medical College Hospital and Research Centre (SRMIEC-ST0123-788).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data used for the evaluation of this study have been presented in the manuscript. Further inquiries should be directed to the corresponding author.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eCernaro, V., Longhitano, E., Casuscelli, C., Peritore, L. \u0026amp; Santoro, D. Hyperphosphatemia in Chronic Kidney Disease: The Search for New Treatment Paradigms and the Role of Tenapanor. \u003cem\u003eInt J Nephrol Renovasc Dis\u003c/em\u003e 17, 151\u0026ndash;161 (2024).\u003c/li\u003e\n\u003cli\u003eShaman, A. M. \u0026amp; Kowalski, S. R. 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Phosphorous metabolism and manipulation in chronic kidney disease. \u003cem\u003eNephrology\u003c/em\u003e 29, 791\u0026ndash;800 (2024).\u003c/li\u003e\n\u003cli\u003eSanchez-Alvarez, J. E. \u003cem\u003eet al.\u003c/em\u003e Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease. FOSFASTUR study. \u003cem\u003eNefrologia\u003c/em\u003e 41, 45\u0026ndash;52 (2021).\u003c/li\u003e\n\u003cli\u003eKalantar-Zadeh, K. \u003cem\u003eet al.\u003c/em\u003e Real-World Scenario Improvements in Serum Phosphorus Levels and Pill Burden in Peritoneal Dialysis Patients Treated with Sucroferric Oxyhydroxide. \u003cem\u003eAm J Nephrol\u003c/em\u003e 47, 153\u0026ndash;161 (2018).\u003c/li\u003e\n\u003cli\u003eBlock, G. \u0026amp; Port, F. K. Calcium phosphate metabolism and cardiovascular disease in patients with chronic kidney disease. \u003cem\u003eSemin Dial\u003c/em\u003e 16, 140\u0026ndash;147 (2003).\u003c/li\u003e\n\u003cli\u003eLiu, J. \u003cem\u003eet al.\u003c/em\u003e Efficacy and Safety of Sucroferric Oxyhydroxide Compared with Sevelamer Carbonate in Chinese Dialysis Patients with Hyperphosphataemia: A Randomised, Open-Label, Multicentre, 12-Week Phase III Study. \u003cem\u003eNephron\u003c/em\u003e 148, 22\u0026ndash;33 (2024).\u003c/li\u003e\n\u003cli\u003eShima, H., Miya, K., Okada, K., Minakuchi, J. \u0026amp; Kawashima, S. Sucroferric oxyhydroxide decreases serum phosphorus level and fibroblast growth factor 23 and improves renal anemia in hemodialysis patients. \u003cem\u003eBMC Res Notes\u003c/em\u003e 11, 1\u0026ndash;8 (2018).\u003c/li\u003e\n\u003cli\u003eTeo, R. Z. C. \u003cem\u003eet al.\u003c/em\u003e Sucroferric oxyhydroxide use in patients on haemodialysis \u0026ndash; real-world experience from an Asian cohort. \u003cem\u003eProceedings of Singapore Healthcare\u003c/em\u003e 32, (2023).\u003c/li\u003e\n\u003cli\u003eBouquegneau, A. \u003cem\u003eet al.\u003c/em\u003e MO543: Efficacy and Influence on the Key Indicators of Mineral-Bone Disorders of the Sucroferric Oxyhydroxide and Sevelamer Carbonate in Hemodialysis Patients. \u003cem\u003eNephrology Dialysis Transplantation\u003c/em\u003e 37, (2022).\u003c/li\u003e\n\u003cli\u003eCovic, A. 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C. \u003cem\u003eet al.\u003c/em\u003e Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. \u003cem\u003eNephrol Dial Transplant\u003c/em\u003e 32, 1363\u0026ndash;1372 (2017).\u003c/li\u003e\n\u003cli\u003ePhan, O. \u003cem\u003eet al.\u003c/em\u003e Effects of Sucroferric Oxyhydroxide Compared to Lanthanum Carbonate and Sevelamer Carbonate on Phosphate Homeostasis and Vascular Calcifications in a Rat Model of Chronic Kidney Failure. \u003cem\u003eBiomed Res Int\u003c/em\u003e 2015, 515606 (2015).\u003c/li\u003e\n\u003cli\u003eI, G., P, S., C, A. \u0026amp; M, A. Sucroferric oxyhydroxide: A novel phosphate binder for the management of mineral bone disease in dialysis patients. \u003cem\u003eBlood, Heart and Circulation\u003c/em\u003e 3, (2019).\u003c/li\u003e\n\u003cli\u003eSprague, S. M. \u0026amp; Floege, J. Sucroferric oxyhydroxide for the treatment of hyperphosphatemia. \u003cem\u003eExpert Opin Pharmacother\u003c/em\u003e 19, 1137\u0026ndash;1148 (2018).\u003c/li\u003e\n\u003cli\u003eGeorgopoulos, C. \u003cem\u003eet al.\u003c/em\u003e #2028 Efficacy and safety of sucroferric oxyhydroxide versus sevelamer carbonate: a systematic review and meta-analysis. \u003cem\u003eNephrology Dialysis Transplantation\u003c/em\u003e 39, (2024).\u003c/li\u003e\n\u003cli\u003eCovic, A. C. \u003cem\u003eet al.\u003c/em\u003e Iron-related parameters in dialysis patients treated with sucroferric oxyhydroxide. \u003cem\u003eNephrology Dialysis Transplantation\u003c/em\u003e 32, 1330\u0026ndash;1338 (2017).\u003c/li\u003e\n\u003cli\u003eSchmid, H. \u0026amp; Lederer, S. R. Novel iron-containing phosphate binders for treatment of hyperphosphatemia. \u003cem\u003eExpert Opin Pharmacother\u003c/em\u003e 16, 2179\u0026ndash;2191 (2015).\u003c/li\u003e\n\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":"CKD, mineral bone disease (MBD), hyperphosphatemia, sevelamer, sucroferric oxyhydroxide (SFOH), intact parathyroid hormone, vascular calcification, serum phosphorus(sP)","lastPublishedDoi":"10.21203/rs.3.rs-8524035/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8524035/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eOur study aimed to evaluate the efficacy and safety of Sucroferric oxyhydroxide (SFOH), an iron-based phosphate binder, compared to sevelamer, a non-calcium-based phosphate binder, in patients with CKD and hyperphosphatemia. Patients undergoing hemodialysis were selected based on their phosphate levels and other relevant parameters. A total of 64 patients were included and divided into two groups: sevelamer (n=32) and SFOH (n=32). Serum samples were collected at baseline and after 12 weeks. Medication adherence was assessed using the MARS-5 score.\u003cstrong\u003e \u003c/strong\u003e64 patients were enrolled however only 60 patients completed the study (30 and 30 to SFOH and sevelamer respectively). In the SFOH group, the mean serum phosphate (sP) levels significantly decreased from baseline, while phosphate levels in the sevelamer group showed only a slight reduction i.e. 7.5±0.6 to 6.1±0.6 mg/dl and 7.6±0.6 to 6.5±0.5 mg/dl respectively. The reduction in serum phosphate was significantly greater in the SFOH group compared to the sevelamer group. This study demonstrates that SFOH effectively reduces serum phosphate levels, increases hemoglobin, and improves medication adherence compared to sevelamer. These findings support the use of SFOH as a beneficial phosphate binder in ESRD patients with hyperphosphatemia. SFOH medication adherence was 93.75% whereas sevelamer exhibited its adherence at 68.75% as per MARS-5 score.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety of Sucroferric Oxyhydroxide compared with sevelamer in Chronic Kidney Disease Patients with Hyperphosphataemia- A Pilot Study ","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-02 07:16:40","doi":"10.21203/rs.3.rs-8524035/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":"ba02a26e-85a6-4c7d-b793-ac43ccfd1bf5","owner":[],"postedDate":"February 2nd, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-05T10:56:41+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-02 07:16:40","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8524035","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8524035","identity":"rs-8524035","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}