Transplant Trial Watch

Preliminary Assessment of Safety and Adherence to a Once Daily Immunosuppression Regimen in Kidney Transplantation: Results of a Randomized Controlled Pilot Study.

Taber, D. J., et al.

Clinical Transplantation 2020: e13844.

The aim of this randomized pilot study was to evaluate the safety and adherence to a novel immunosuppression regimen of extended release-tacrolimus (LCP-tac), everolimus and prednisone, administered once-daily, in kidney transplant recipients.

Patients were randomized 1:1 to receive LCP-tac, everolimus, and prednisone or LCP-tac, mycophenolate Twice daily (BID), and prednisone.

40 adult kidney transplant recipients.

The adherence outcome was measured as the estimated change in self-reported medication adherence from baseline to 6 months. The safety outcome was the analysis of treatment failure. The tolerability outcomes were the change in self-reported side effect burden, change in quality of life (QOL) and severe adverse events.

6 months

CET Conclusions
The pilot, single-centre, open-label randomised controlled trial aimed to provide preliminary safety, tolerability and adherence data for a once-daily regimen of LCP-tacrolimus and everolimus compared with standard regimen of LCP-tacrolimus and twice-daily mycophenolate in adult kidney transplant recipients. Forty patients were randomised at 3 months posttransplant and all completed the 6-month follow up. Groups were similar at baseline. These preliminary and short-term data showed that there were no differences in adverse events or clinical outcomes (acute rejection, graft loss or death) between the groups at 6 months. Tolerability was measured using side-effect burden and quality of life and both measures did not show any differences between groups at 6 months. Adherence was also not significantly different at 6 months.

Jadad score

Data analysis
Per protocol analysis

Allocation concealment

Trial registration - NCT02954198

Funding source
Industry funded