Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
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- dc.contributor.author Budde, Klemens
- dc.contributor.author Pascual Santos, Julio
- dc.contributor.author Grinyó, Josep M.
- dc.date.accessioned 2023-02-16T07:10:55Z
- dc.date.available 2023-02-16T07:10:55Z
- dc.date.issued 2022
- dc.description.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.
- dc.format.mimetype application/pdf
- dc.identifier.citation 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
- dc.identifier.doi http://dx.doi.org/10.3389/ti.2021.10225
- dc.identifier.issn 0934-0874
- dc.identifier.uri http://hdl.handle.net/10230/55803
- dc.language.iso eng
- dc.publisher Springer
- dc.relation.ispartof Transpl Int. 2022 Mar 21;35:10225
- dc.rights © 2022 Budde, Rostaing, Maggiore, Piotti, Surace, Geraci, Procaccianti, Nicolini, Witzke, Kamar, Albano, Büchler, Pascual, Gutiérrez-Dalmau, Kuypers, Wekerle, Głyda, Carmellini, Tisone, Midtvedt, Wennberg and Grinyó. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.rights.uri http://creativecommons.org/licenses/by/4.0/
- dc.subject.keyword LCPT
- dc.subject.keyword Immunosuppression
- dc.subject.keyword Kidney
- dc.subject.keyword Pharmacokinetics
- dc.subject.keyword Tacrolimus
- dc.subject.keyword Transplantation
- dc.title Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/publishedVersion