Transplant Trial Watch

Impact of Once- Versus Twice-Daily Tacrolimus Dosing on Medication Adherence in Stable Renal Transplant Recipients: A Canadian Single-Center Randomized Controlled Trial.

Paterson, T. S. E., Demian, M. et al. (2019).

Canadian Journal of Kidney Health & Disease [record in progress].

This study aimed to evaluate the impact of once-daily vs twice-daily tacrolimus dosing regimens on adherence in kidney transplant patients.

Patients were randomized to receive either the once-daily Advagraf (tacrolimus extended release; n=19) or twice-daily Prograf (tacrolimus; n=19).

46 kidney transplant recipients were recruited, however, 38 renal transplant recipient completed all phases of this study.

Adherence outcomes were measured using the medication event monitoring system (MEMS), medication possession ratio (MPR%) and the transplant effects questionnaire (TEQ).

4 months

CET Conclusions
The objective was to compare the adherence of once-daily tacrolimus versus twice-daily tacrolimus in stable kidney transplant recipients who were at least 1 year posttransplantation. Adherence was measured by electronic monitoring, pharmacy refill data and by self-report. The study period was 4 months and 38 out of a total of 46 randomised patients completed the study. Patients were randomised by trained research assistants using a random number generator. On average, participants were between seven and eight years posttransplant. Electronic monitoring showed that the once-daily group had a higher mean percentage of adherence compared with the twice-daily group. According to the pharmacy refill data (measured as the medication possession ratio (MPR), 79% of the once-daily group was adherent compared with 47% of the twice-daily group. There were no significant group differences for self-reported medication adherence. This small, underpowered study provides weak evidence for improved adherence in the once-daily group compared to twice-daily tacrolimus.

Jadad score

Data analysis
Per protocol analysis

Allocation concealment

Trial registration -NCT01334333

Funding source
Industry & non-industry funded