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

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 formulati...

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Detalhes bibliográficos
Autores: Budde, Klemens, Pascual Santos, Julio, Grinyó, Josep M.
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Recursos:Universitat Pompeu Fabra
Repositorio:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/55803
Acesso em linha:http://hdl.handle.net/10230/55803
http://dx.doi.org/10.3389/ti.2021.10225
Access Level:acceso abierto
Palavra-chave:LCPT
Immunosuppression
Kidney
Pharmacokinetics
Tacrolimus
Transplantation
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spelling Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across EuropeBudde, KlemensPascual Santos, JulioGrinyó, Josep M.LCPTImmunosuppressionKidneyPharmacokineticsTacrolimusTransplantationBackground: 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.Springer202320232022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/55803http://dx.doi.org/10.3389/ti.2021.10225reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésTranspl Int. 2022 Mar 21;35:10225© 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.http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/558032026-06-12T07:21:37Z
dc.title.none.fl_str_mv Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
title Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
spellingShingle Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
Budde, Klemens
LCPT
Immunosuppression
Kidney
Pharmacokinetics
Tacrolimus
Transplantation
title_short Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
title_full Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
title_fullStr Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
title_full_unstemmed Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
title_sort Prolonged-release once-daily formulation of tacrolimus versus standard-of-care tacrolimus in de novo kidney transplant patients across Europe
dc.creator.none.fl_str_mv Budde, Klemens
Pascual Santos, Julio
Grinyó, Josep M.
author Budde, Klemens
author_facet Budde, Klemens
Pascual Santos, Julio
Grinyó, Josep M.
author_role author
author2 Pascual Santos, Julio
Grinyó, Josep M.
author2_role author
author
dc.subject.none.fl_str_mv LCPT
Immunosuppression
Kidney
Pharmacokinetics
Tacrolimus
Transplantation
topic LCPT
Immunosuppression
Kidney
Pharmacokinetics
Tacrolimus
Transplantation
description 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.
publishDate 2022
dc.date.none.fl_str_mv 2022
2023
2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/55803
http://dx.doi.org/10.3389/ti.2021.10225
url http://hdl.handle.net/10230/55803
http://dx.doi.org/10.3389/ti.2021.10225
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Transpl Int. 2022 Mar 21;35:10225
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Springer
publisher.none.fl_str_mv Springer
dc.source.none.fl_str_mv reponame:Repositorio Digital de la UPF
instname:Universitat Pompeu Fabra
instname_str Universitat Pompeu Fabra
reponame_str Repositorio Digital de la UPF
collection Repositorio Digital de la UPF
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812455

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