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: Adolescent patients in 18 German and Austrian centers for pediatric kidney transplantation one year before planned transfer 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 eGFR at adults hospital phase.
Results: 220 Patients were assessed for eligibility. A total of 102 patients were randomized, 49 to the intervention (59% males, mean age 18) and 53 to the control group (51% males, mean age 18 years). Six patients in the intervention group discontinued the study because they didn’t like the case management and two in the intervention group (no reason given). In addition 29 patients (15 intervention vs 14 control patients) were lost of follow up. In 5 patients (3 intervention vs 2 control patients) dialysis and/or transplantation was necessary. At the end we analyzed 84 patients in the modified intention-to-treat (mITT) analysis (38 intervention vs 46 control patients) and 60 patients in the per protocol (pp) analysis (25 intervention vs 35 control patients). No change in CoV was observed for the mITT analysis (ls mean difference [95% CI]: 0.01 [-0.17, 0.18], p=0.9574) and for the pp analysis analysis (ls mean difference [95% CI]: -0.01 [-0.19, 0.16], p=0.8748). Actually, mean eGFR at adult clinic outpatient phase was lower in the intervention group compared to control (46,8 in the intervention vs 50,6 in the control group, ls mean difference [95% CI]: -3.7 [-9.0, 1.5], p=0.161).

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.