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.
Aims
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.
Interventions
Patients were randomized 1:1 to receive LCP-tac, everolimus, and prednisone or LCP-tac, mycophenolate Twice daily (BID), and prednisone.
Participants
40 adult kidney transplant recipients.
Outcomes
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.
Follow-up
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.
Data analysis
Per protocol analysis
Trial registration
ClinicalTrials.gov - NCT02954198