Tacrolimus Pharmacokinetic Subpopulations
Recruiting now
Conditions studied: Kidney Transplant Failure and Rejection, Immunosuppression-related Infectious Disease
In brief
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.
Key facts
- Study ID
- NCT04526431
- Run by
- University Hospital, Grenoble
- People needed
- 180
- Starts
- 2020-07-28
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2021-02-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Grenoble University Hospital — Grenoble, Auvergne-Rhône-Alpes, France (enrolling)
- Saint Etienne University Hospital — Saint-Etienne, Auvergne-Rhône-Alpes, France
Full record on ClinicalTrials.gov
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