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].


Aims
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.

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

Participants
62 adult kidney transplant recipients.

Outcomes
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.

Follow-up
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
3

Data analysis
Per protocol analysis

Allocation concealment
Yes

Trial registration
UMIN000033089

Funding source
Not reported