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1. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study.

Author

Kamar, Nassim, Cassuto, Elisabeth, Piotti, Giovanni, Govoni, Mirco, Ciurlia, Giorgia, Geraci, Silvia, Poli, Gianluigi, Nicolini, Gabriele, Mariat, Christophe, Essig, Marie, Malvezzi, Paolo, Le Meur, Yannick, Garrigue, Valerie, Del Bello, Arnaud, and Rostaing, Lionel

Subjects
BIOAVAILABILITY, DRUG therapy, COMPARATIVE studies, DRUG administration, EXPERIMENTAL design, TACROLIMUS, IMMUNOSUPPRESSIVE agents, KIDNEY transplantation, LONGITUDINAL method, RESEARCH methodology, MEDICAL cooperation, RESEARCH, STATISTICAL sampling, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness
Abstract

Introduction: Different prolonged-release formulations of tacrolimus are available. To date, the pharmacokinetic (PK) profile of LCP-tacrolimus (LCPT; Envarsus®) has not been compared with PR-Tac (Advagraf®) in de novo kidney transplant recipients. These profiles will guide clinical recommendations for the initiation and dose titration strategies of once-daily tacrolimus formulations.Methods: This randomized, parallel-group, open-label, multicenter PK study randomized 75 de novo, adult, white kidney transplant recipients to LCPT 0.17 mg/kg/day (n = 37) or PR-Tac 0.20 mg/kg/day (n = 38) for 4 weeks. Dose adjustments were permitted to target a pre-defined therapeutic range based on measured trough blood concentrations.Results: PK analysis (days 1, 3, 7 and 14) included 68 patients (LCPT, n = 33; PR-Tac, n = 35). Similar proportions of patients were within the pre-defined therapeutic tacrolimus trough blood concentration range, with < 12% in each group having below-target trough levels over the study period. LCPT demonstrated ~ 30% greater relative bioavailability [LCPT/PR-Tac adjusted geometric mean ratio: day 3, 1.32 (p = 0.007); day 7, 1.25 (p = 0.051); day 14, 1.43 (p = 0.002)] and ~ 30% lower peak-to-trough percentage fluctuation of blood concentration [LCPT/PR-Tac adjusted geometric mean ratio: day 3, 0.70 (p < 0.001); day 7, 0.68 (p < 0.001); day 14, 0.73 (p = 0.004)] in addition to longer time to maximum blood concentration (tmax), lower maximum concentration (Cmax) and a consistently lower daily dose (~ 40% dose reduction with LCPT vs. PR-Tac by day 28). Safety profiles were similar.Conclusion: In de novo kidney transplant recipients, prolonged-release formulations of tacrolimus can reach therapeutic concentrations in the immediate post-transplant period. LCPT has greater relative bioavailability and lower peak-to-trough fluctuation compared with PR-Tac.Trial Registration: Registered at ClinicalTrials.gov; study number NCT02500212.Funding: Chiesi Farmaceutici S.p.A. [ABSTRACT FROM AUTHOR]

Published
2019
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2. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study

Author

Mirco Govoni, Paolo Malvezzi, Valérie Garrigue, Arnaud Del Bello, Yannick Le Meur, Giorgia Ciurlia, Silvia Geraci, Elisabeth Cassuto, Lionel Rostaing, Nassim Kamar, Gianluigi Poli, Gabriele Nicolini, Marie Essig, Christophe Mariat, Giovanni Piotti, Michel, Geneviève, Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département de Néphrologie et Transplantation d'organes [CHU Toulouse], Pôle Urologie - Néphrologie - Dialyse - Transplantations - Brûlés - Chirurgie plastique - Explorations fonctionnelles et physiologiques [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service de néphrologie et transplantation rénale [Nice], Hôpital Pasteur [Nice] (CHU), Kidney and Pancreas Transplantation, Global Clinical Development, CHU Saint-Etienne, Pharmacologie des Immunosuppresseurs et de la Transplantation (PIST), Université de Limoges (UNILIM)-CHU Limoges-Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST FR CNRS 3503)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de néphrologie, dialyse, aphérèses et transplantation, CHU Grenoble-Université Grenoble Alpes [2016-2019] (UGA [2016-2019]), Service de Nephrologie-Transplantation Rénale et Hémodialyse [CHRU Brest], Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de Néphrologie, Dialyse et Transplantation (Hôpital Lapeyronie [Montpellier] CHU), Hôpital Lapeyronie [Montpellier] (CHU), Departements of nephrology and organ transplantation [Toulouse], Hôpital de Rangueil, CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble, Département de Néphrologie et Transplantation d'organes, Service de Néphrologie - Hypertension Artérielle Dialyse - Transplantation, CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Centre Hospitalier Universitaire de Nice (CHU Nice), Service de néphrologie et tranplantation, CHU Saint-Etienne-Hôpital nord, Service de Néphrologie, Dialyse, Transplantations [CHU Limoges], CHU Limoges, Département de Diabétologie, Urologie, Néphrologie et Endocrinologie (CHU-Grenoble), CHU Grenoble, CHRU Brest - Service de Nephrologie (CHU - BREST - Nephrologie), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Néphrologie, and Hôpital Lapeyronnie

Subjects
Adult, Male, medicine.medical_specialty, [SDV.IMM] Life Sciences [q-bio]/Immunology, [SDV]Life Sciences [q-bio], Urology, Cmax, Biological Availability, 030230 surgery, 030226 pharmacology & pharmacy, Kidney transplant, Drug Administration Schedule, Tacrolimus, PR Tac, 03 medical and health sciences, 0302 clinical medicine, Therapeutic index, Pharmacokinetics, Prolonged release, medicine, Humans, Pharmacology (medical), Molecular Targeted Therapy, Prospective Studies, De novo kidney transplantation, ComputingMilieux_MISCELLANEOUS, Original Research, business.industry, Envarsus, Advagraf, General Medicine, Middle Aged, Kidney Transplantation, 3. Good health, Bioavailability, LCPT, Treatment Outcome, Multicenter study, Research Design, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, business, Immunosuppressive Agents
Abstract

Introduction Different prolonged-release formulations of tacrolimus are available. To date, the pharmacokinetic (PK) profile of LCP-tacrolimus (LCPT; Envarsus®) has not been compared with PR-Tac (Advagraf®) in de novo kidney transplant recipients. These profiles will guide clinical recommendations for the initiation and dose titration strategies of once-daily tacrolimus formulations. Methods This randomized, parallel-group, open-label, multicenter PK study randomized 75 de novo, adult, white kidney transplant recipients to LCPT 0.17 mg/kg/day (n = 37) or PR-Tac 0.20 mg/kg/day (n = 38) for 4 weeks. Dose adjustments were permitted to target a pre-defined therapeutic range based on measured trough blood concentrations. Results PK analysis (days 1, 3, 7 and 14) included 68 patients (LCPT, n = 33; PR-Tac, n = 35). Similar proportions of patients were within the pre-defined therapeutic tacrolimus trough blood concentration range, with

Published
2019
Full Text
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