Transplant Trial Watch

Prolonged-Release Once-Daily Formulation of Tacrolimus Versus Standard-of-Care Tacrolimus in de novo Kidney Transplant Patients Across Europe.

Budde, K., et al.

Transplant International 2022; 35: 10225.

This study aimed to compare the posttransplant outcomes of LCP-tacrolimus (LCPT) versus current standard-of-care tacrolimus (immediate-release tacrolimus (IR-Tac) or prolonged-release tacrolimus (PR-Tac), according to centre preference) in de novo kidney transplant recipients.

Participants were randomly assigned to receive either LCPT or current standard-of-care tacrolimus.

403 de novo kidney transplant recipients (≥18 years).

The primary outcome was the tacrolimus total daily dose (TDD). The secondary clinical outcomes were treatment failure, treatment discontinuation, delayed graft function, local diagnosis of acute rejection requiring treatment, and concomitant immunosuppressive medications.

6 months

CET Conclusions
This phase IV multicentre study compared the use of LCP-tacrolimus with standard of care (either standard (SR) or prolonged release (PR) tacrolimus depending on centre preference) in de-novo kidney transplant recipients. The authors demonstrated that despite a significantly lower total daily dose in the LCP-tacrolimus group, there was no difference in trough levels or short-term clinical outcomes between groups. The study is fairly well-designed, although the decision to allow the control arm to receive SR or PR tacrolimus at centre discretion is slightly odd as the study is left underpowered to show a difference in comparison to either in isolation. It is not really clear if there is any clinical benefit to an overall dose reduction; trough levels are similar so overall exposure is likely to be equivalent. Certainly, the study provides confirmation that the LCP-tacrolimus formulation is safe and equivalent in clinical efficacy to SR and PR formulations.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Trial registration - NCT02432833

Funding source
Industry funded