Transplant Trial Watch

A report of a prospective randomized trial of extended-release tacrolimus versus immediate release tacrolimus after liver transplantation with anti-thymocyte induction in a steroid free protocol.

Helmick, R. A., et al.

Clinical Transplantation 2023 [record in progress].


Aims
This study aimed to investigate the safety and effectiveness of extended-release tacrolimus (XRT) in comparison to immediate release tacrolimus (IRT) following liver transplantation in a steroid-free protocol with rabbit anti-thymocyte globulin (RATG).

Interventions
Participants were randomised to either the XRT group or the IRT group.

Participants
110 liver transplant recipients.

Outcomes
The main outcomes were the assessment of creatinine and eGFR, adverse events, rejection and quality of life.

Follow-up
12 months

CET Conclusions
This single centre study randomised 110 liver transplant recipients to receive standard release or extended-release tacrolimus in conjunction with rabbit ATG following liver transplantation. Renal function did not differ between groups at any point post-transplant. There were also no statistically significant differences in quality of life, rejection rates or adverse event rates between groups. Overall, the study appears well-conducted and reported. It demonstrates that extended-release tacrolimus provides an alternative to standard release tacrolimus in this patient population, although does not provide any evidence of measurable clinical benefit within the first year.

Jadad score
2

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT03828058.

Funding source
Industry funded