Transplant Trial Watch

Pilot Study Comparing the Efficacy, Safety, Convertibility, and Tacrolimus Trough Levels of Twice-Daily Tacrolimus (Prograf) to Once-Daily Tacrolimus (Advagraf) Among Standard-Risk Kidney Transplant Patients at the National Kidney and Transplant Institute.

Danguilan, R. A., Lamban, A. et al. (2019).

Transplantation Proceedings. 51(8): 2615-2619.


Aims
This study aims to investigate the efficacy, safety, convertibility, and tacrolimus trough level of once-daily tacrolimus at the end of 6 months post-transplant.

Interventions
Patients were randomized to either Group A (twice-daily tacrolimus at 0.08 to 0.1 mg/kg in 2 divided doses) or Group B (once-daily tacrolimus at a dose of 0.08 to 0.1 mg/kg once a day).

Participants
40 standard-risk primary kidney transplant patients.

Outcomes
Outcomes were assessed as tacrolimus dose and trough levels, area under the curve (AUC), maximum concentration (Cmax) and time to achieve maximum concentration (Tmax). Graft and patient survival was also assessed.

Follow-up
6-9 months

CET Conclusions
This small single centre study from the Phillipines investigates the conversion from twice-daily to once-daily tacrolimus at 3 months post-transplant in stable living donor kidney recipients. The authors conclude that conversion is safe with equivalent outcomes. The sample size here is too small to meet the primary study objectives (to demonstrate equivalent efficacy and safety of the two formulations) and no sample size calculation is presented. Randomisation was also inadequate – with alternate allocation to study and control arms meaning that there was no allocation concealment.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
No

Trial registration
N/A

Funding source
Not reported