Transplant Trial Watch

Tacrolimus 4-hour monitoring in liver transplant patients is non-inferior to trough monitoring: the randomized controlled FK04 trial.

Ruijter, B. N., et al.

Clinical Transplantation 2022 [record in progress].

The aim of this study was to compare the effect of 4-hour level (C4) monitoring of tacrolimus BID (Prograft) to trough (C0) monitoring in stable liver transplant patients.

Participants were randomly assigned C0 or C4 monitoring.

50 liver transplant recipients on a stable calcineurin inhibitor(CNI)-based regimen.

The primary outcome was renal function. The secondary outcomes were the incidence of treated biopsy-proven acute rejection, blood pressure and metabolic parameters.

12 weeks

CET Conclusions
The single-centre randomised controlled trial tested the hypothesis that C4 monitoring was superior to C0 monitoring of tacrolimus BID regarding renal function in stable liver transplant recipients. The study was adequately powered and 50 patients were randomised according to blinded envelopes. All randomised patients completed the study. The intention to treat analysis showed that renal function at 12 weeks was similar between groups. Patient and graft survival was 100% at 12 weeks and most secondary outcomes were similar.

Jadad score

Data analysis
Strict intention-to-treat analysis

Allocation concealment

Trial registration

Funding source
Industry funded