Abstract: TH-PO1119
The TRANSNephro Study Examining a New Transition Model for Post-Kidney Transplant Adolescents: A Multicenter, Randomized Controlled Trial
Session Information
- Late-Breaking Posters
November 02, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Pediatric Nephrology
- 1900 Pediatric Nephrology
Authors
- Pape, Lars, Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
- Großhennig, Anika, Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
- Pruefe, Jenny, Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
- Kreuzer, Martin, Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Group or Team Name
- Study Group of the German Society of Pediatric Nephrology
Background
Allograft loss is highest in adolescents due to non-adherence and transfer of health care. This multicenter, randomized controlled trial aimed to evaluate whether support by a central case manager and a corresponding app during transition may improve the outcome.
Methods
Adolescent patients in 18 German and Austrian centers one year before planned transfer were randomized 1:1 to a control group that received transition as by center standard or to an intervention group. The intervention consisted of 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 Calcineurininhibitor as a surrogate marker for medication adherence. Important secondary endpoints were acute rejections, graft loss, eGFR, and quality of life. For the assessment, least square (LS) mean differences and corresponding 95% confidence intervals (CIs) were estimated within an analysis of covariance (ANCOVA) model.
Results
A total of 220 patients was assessed for eligibility. Of these, 102 patients were randomized, 49 to the intervention and 53 to the control group. 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 difference in CoV was observed between the two groups, neither in the mITT (LS mean difference [95% CI]:0.01 [-0.17, 0.18], p=0.9574) nor in the PP analysis (LS mean difference [95% CI]:-0.01 [-0.19, 0.16], p=0.8748). We observed a trend for a lower mean eGFR at adult clinic outpatient phase in the intervention group. We saw only low numbers of graft-related events and observed no differences between the groups with respect to quality of life.
Conclusion
The addition of our case-manager-based intervention to standard of care transition, did not improve adherence and other outcome parameters in adolescent kidney graft recipients. We assume that non-adherent patients may have decided not to take part in the trial, as adherence was already good at study start. It thus is a future challenge to design multicenter trials on transition that include multiple interventions for a better transition in order to stop the long-term decrease in graft function.