Tuesday March 29, 2022 - 17:00 to 18:10
Health Care Transition of Adolescents After Kidney Transplantation in Germany and Austria – The Randomized Controlled TRANSNephro Trial
Martin Kreuzer1, Jenny Prüfe1, Annika Grosshennig2, Lars Pape1.
1Pediatrics II, University Hospital of Essen, Essen, Germany; 2Biostatistics, Hannover Medical School, Hannover, Germany
Study Group of the German Society for Pediatric Nephrology.
Introduction: Adolescence is the age with the highest rate of graft losses because of non-adherence and the transfer from pediatric to adult care. Health care transition in German nephrologic centers is not standardized. This randomized controlled trial aimed to evaluate whether support during transition by a central case manager and a corresponding app improves results.
Methods: One year before planned transfer, adolescent patients in 18 German and Austrian centers for pediatric kidney transplantation were randomized to a control group that received transition as by center standard or to an intervention group, in which patients were integrated in the “Berlin Transition Program” including a central case manager, a communication app, and joined transition rounds for one year before and one after transfer to adult care. Primary endpoint was the coefficient of variation (CoV) of the trough level of the calcineurininhibitor as a surrogate marker for medication adherence. Important secondary endpoints were acute rejection, graft losses and quality of life.
Results: 220 Patients were assessed for eligibility. 121 were excluded, 116 of whom declined to participate. 98 patients could be randomized, 46 in the intervention and 52 in the control group and be transferred with a mean of 19.6 vs. 19.0 years. 7 patients in the intervention group discontinued the study because they didn’t like the case management and one in the intervention group (no reason given). 19 patients were lost of follow up and 4 had to be excluded because the transfer was delayed. 27 vs. 37 patients could be analyzed. Mean serum-creatinine and CoV were comparable between both groups with 141.6 ±76.3 and 135.8 ±74.1 µmol/l (p=0.75) and 18.3 ±12 % and 19,8 ±13 % (p=0.65). The primary endpoint, the CoV at study end was comparable between both study groups with 24.6% ±15.7 vs. 23.9% ±15.2 p=0.90. There were also no differences at study end for s-creatinine, acute rejections and graft loss. S-creatinine increased (not statistically siginificant) from 142 ±76 to 192 ±167 µmol/l vs. 136 ±74 to 172 ±177 µmol/l in both groups with no difference between the groups (p=0.74).
Conclusion: The addition of the Berlin Transition Program to standard of care transition, mainly based on a case manager, did not improve adherence and other outcome parameters in adolescent kidney graft recipients. Non-adherent patients may have decided not to take part in the trial, as adherence was good at study start. It will become difficult to design future multicenter trials in transition that include multiple interventions for a better transition in order to stop the decrease in graft function that can still be documented.