The TRANSNephro-study examining a new transition model for post-kidney transplant adolescents - Results of a multicenter, randomized-controlled trial

Abstract Allograft loss after pediatric kidney transplantation (KTx) is highest in adolescents and young adults. Non-adherence and Health Care Transition (HCT) are important factors, but others do also contribute. Patients were randomized 1:1. The intervention group (IG) included a central case manager, a communication app, and joined transition rounds for one year before and one after transfer. Primary endpoint was the coefficient of variation (CoV) of the trough level of the calcineurin inhibitor as a surrogate marker for medication adherence associated with graft loss. Least square (LS) mean differences and corresponding 95% confidence intervals (CIs) were estimated using an ANCOVA model. 220 patients were assessed for eligibility. 49 patients were randomized to the intervention group and 53 to the control group (CG). We analyzed 84 patients in the modified intention-to-treat analysis (38IG,46CG) and 60 in the per protocol analysis (25IG,35CG) No difference in CoV was observed. We saw low numbers of graft-related events and observed no differences with respect to quality of life. BTP did not improve adherence and other outcome parameters. Non-adherent patients may have decided not to take part, as adherence of participants was already good at study start. It thus is a future challenge to design multicenter trials on HCT that include multiple interventions.