Transplant Trial Watch

Two-year outcomes of low-exposure extended-release tacrolimus and mycophenolate mofetil regimen in de novo kidney transplantation: A multi-center randomized controlled trial.

Hidaka, Y., et al.

Clinical Transplantation 2022 [record in progress].

This study aimed to determine the minimum effective concentration of once-daily extended-release tacrolimus (TACER) by conducting pharmacokinetic monitoring of adult kidney transplant patients.

Participants were randomised to either standard-exposure or low-exposure TACER.

62 adult kidney transplant recipients.

The primary endpoints were acute rejection, graft survival and patient survival. Secondary endpoints were incidence of cytomegalovirus infection and de novo donor-specific antibodies (dnDSA) production.

2 years

CET Conclusions
The randomised controlled trial compared standard-exposure versus low-exposure once-daily tacrolimus in living donor kidney transplant recipients. Sixty-two participants were randomised using web-based randomisation. The primary outcome acute rejection was not different between groups. The histology of the 1-month and 1-year protocol biopsies was similar. Graft and patient survival were 100% and eGFR was similar between groups up to 2 years posttransplant. De novo donor-specific antibodies were confirmed in four cases in the low exposure group versus no cases in the standard exposure group up to 2 years posttransplant. The authors suggest that further data on the long-terms effects are needed.

Jadad score

Data analysis
Per protocol analysis

Allocation concealment

Trial registration

Funding source
Not reported