Tacrolimus Pharmacokinetic Subpopulations
Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C/D Ratio
University Hospital, Grenoble
180 participants
Jul 28, 2020
OBSERVATIONAL
Conditions
Summary
This prospective study will investigate the concentrations of tacrolimus metabolites (M-I and M-III) over the four first years post-transplantation. A differential metabolism might result in different metabolites' concentration and explain a kidney survival difference between "high rate metabolism" (defined as a concentration/dose ratio, C/D ratio, lower than 1.04 µg/l/mg) and other patients. The primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either \< or \>= 1.04 µg/l/mg, in order to detect differences in tacrolimus metabolization between these groups.
Eligibility
Inclusion Criteria7
- Kidney transplant patients at the CHUGA, CHU Saint-Etienne or CHU Clermont-Ferrand, whose new transplant is no more than 7 days old (inclusive)
- Patients initially treated with tacrolimus as an immunosuppressant, combined with mycophenolate (MMF), mycophenolic acid (MPA) or everolimus (EVR), with or without corticotherapy.
- No plans to remove tacrolimus from the patient's immunosuppressive treatment (e.g. no plans to switch to belatacept a priori), during the first 4 years post-transplantation.
- Affiliation to or beneficiary of a social security scheme
- Able to read and understand the terms of the protocol
- Informed consent obtained, including specific consent for genetic analysis of target genes.
- For women of childbearing potential, presence of effective contraception (already acquired for patients treated with mycophenolic acid as an immunosuppressant).
Exclusion Criteria8
- Contraindication to the use of tacrolimus
- Patient already treated with tacrolimus at the time of transplantation
- Pregnant, parturient or breastfeeding women
- Patient deprived of liberty by judicial or administrative decision
- Patient under guardianship or curatorship, or receiving forced psychiatric care
- Person admitted to a health or social institution
- Subject cannot be contacted in case of emergency
- Subject in period of exclusion from another study
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Dosage form of tacrolimus (extended release tacrolimus or immediate release tacrolimus)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04526431