Abstract: TH-OR118
Telemedical Management vs. Standard Aftercare Following Kidney Transplantation: The SmartNTx Trial
Session Information
- Late-Breaking Research Orals: Dialysis and Transplantation
October 22, 2026 | Location: Four Seasons Ballroom 2, Convention Center
Abstract Time: 05:42 PM - 05:54 PM
Category: Transplantation
- 2002 Transplantation: Clinical
Authors
- Schiffer, Mario, University Hospital Erlangen, Erlangen, BY, Germany
- Pape, Lars, Universitat Duisburg-Essen, Essen, NRW, Germany
- Roll, Paul, IGES, Berlin, Germany
- Roller, Roland, Deutsches Forschungszentrum fur Kunstliche Intelligenz GmbH, Berlin, Germany
- Naik, Marcel, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
- Halleck, Fabian, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
- Witzke, Oliver, University Duisburg-Essen, Essen, Germany
- Budde, Klemens, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany
Background
Kidney-transplant recipients require a complex treatment regimen and lifelong self-management. Whether adding a certified telemedicine application within a physician-led aftercare pathway improves outcomes, as compared with standard aftercare alone, is unknown.
Methods
In a 12-month RCT at three German transplant centers, we assigned adult and pediatric kidney-transplant recipients in the first year posttransplant to standard aftercare (control group) or standard aftercare plus telemedicine aftercare with bidirectional data transfer through a certified application (intervention group). The primary outcome was a 0-7 composite score (1 point each) incorporating adherence, tacrolimus variability, hospitalization, de-novo donor-specific antibodies (dnDSA), eGFR, and blood pressure, and was assessed in adults using an ordinal mixed-effects logistic regression model.
Results
We randomly assigned 391 patients. 381 (including 27 children) were included in the modified ITT analysis. Among adults, the mean composite score was 5.48 in the intervention group and 5.25 in the control group (odds ratio (OR) for a higher score, 1.45; 95% CI, 0.96 to 2.20; P=0.08). Individual components of composite endpoint (IG vs control): BAASIS: OR 1.36 95% CI (0.8 to 2.34), tacrolimus variability <30%: OR 1.32 (0.82 to 2.14), unplanned hospitalizations: OR 1.34 (0.88-2.04); unplanned hospitalization >10 nights: OR 1.80 (0.81 to 4.19); de novo DSA: OR 0.78 (0.27 to 2.14), blood pressure: OR 1.05 (0.64 to 1.72) and eGFR >45ml/min: OR 0.93 (0.57 to 1.50). Adherence and tacrolimus variability and hospitalizations favored the intervention group, whereas dnDSA, eGFR and blood pressure were similar between groups. Mental health-related quality of life improved over time with the intervention (0.13 points/month; 95% CI, 0.05 to 0.21) and patient satisfaction was high (94.3%).
Conclusion
In this first proof-of-concept study, telemedical management did not significantly improve a composite outcome after kidney transplantation. However, several components and mental health–related quality of life favored the intervention resulting in high patient satisfaction.
Acknowledgment
Funded by the Joint Federal Committee of Germany; ClinicalTrials.gov number, NCT05897047
Figure 1. Forest plot of OR for prespecified indicators
Funding
- Government Support - Non-U.S.