Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe

Budde, Klemens; Pascual Santos, Julio; Grinyó, Josep M.

doi:http://dx.doi.org/10.3389/ti.2021.10225

Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe

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Budde K, Rostaing L, Maggiore U, Piotti G, Surace D, Geraci S, et al. Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe. Transpl Int. 2022 Mar 21;35:10225. DOI: 10.3389/ti.2021.10225

Abstract

Background: Tacrolimus is the calcineurin inhibitor of choice for preventing acute rejection episodes in kidney transplant patients. However, tacrolimus has a narrow therapeutic range that requires regular monitoring of blood concentrations to minimize toxicity. A new once-daily tacrolimus formulation, LCP-tacrolimus (LCPT), has been developed, which uses MeltDose™ drug-delivery technology to control drug release and enhance overall bioavailability. Our study compared dosing of LCPT with current standard-of-care tacrolimus [immediate-release tacrolimus (IR-Tac) or prolonged-release tacrolimus (PR-Tac)] during the 6 months following de novo kidney transplantation. Comparisons of graft function, clinical outcomes, safety, and tolerability for LCPT versus IR-Tac/PR-Tac were also performed. Methods: Standard immunological risk patients with end-stage renal disease who had received a de novo kidney transplant were randomized (1:1) to LCPT (N = 200) or IR-Tac/PR-Tac (N = 201). Results: Least squares (LS) mean tacrolimus total daily dose from Week 3 to Month 6 was significantly lower for LCPT than for IR-Tac/PR-Tac. Although LS mean tacrolimus trough levels were significantly higher for LCPT than IR-Tac/PR-Tac, tacrolimus trough levels remained within the standard reference range for most patients. There were no differences between the groups in treatment failure measures or safety profile. Conclusion: LCPT can achieve similar clinical outcomes to other tacrolimus formulations, with a lower daily dose. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT02432833.