Transplant Trial Watch

Results of a multicenter, randomized trial examining a new transition model for post-kidney transplant adolescents.

Kreuzer, M., et al.

Scientific Reports 2025; 15(1): 11459.


Aims
This study aimed to examine the effectiveness of a new structured transition program with supplementary smartphone apps for improving treatment adherence during Health Care Transition (HCT) in adolescents and young adults (AYA) kidney transplant recipients.

Interventions
Participants were randomly assigned to two groups: the intervention group which received the structured transition program; and the control group that received standard care.

Participants
102 adolescents and young adults (AYA) kidney transplant patients.

Outcomes
The primary outcome was therapy adherence. The secondary outcomes were estimated glomerular filtration rate (eGFR), serum creatinine, patient survival, graft survival, acute rejection and pateint-reported outcomes.

Follow-up
24-26 months

CET Conclusions
The rate of kidney graft loss amongst adolescent and young adult recipients is high. This is attributed to the transition from paediatric to adult care systems, with the concomitant loss of supervision and resultant reduction in adherence to immunosuppression. To address this, structured Health Care Transition (HCT) plans have been developed. This randomized trial sought to evaluate the efficacy of a HCT plan (included case managers, a communications app and joint transition ward rounds) in improving adherence amongst adolescent kidney transplant recipients who were planned for transition to adult care. The primary outcome was the coefficient of variance (CoV) of tacrolimus trough levels measured over a 2-year period. 102 patients were randomised equally between the HCT group and a control (standard of care) group. There was no difference in adherence (as measured by the CoV) found between the two groups. In addition to a small sample size, the study is limited by a poorly chosen primary outcome measure – CoV has been shown to be a poor predictor of tacrolimus adherence in multiple reports. Also, as the authors acknowledge, there was significant risk of selection bias as patients who agree to take part in studies are inherently more motivated, limiting the capacity for improvement in both groups.

Jadad score
2

Data analysis
Modified intention-to-treat analysis

Allocation concealment
No

Trial registration
ISRCTN22988897

Funding source
Non-industry funded