NCT04526431 Tacrolimus Pharmacokinetic Subpopulations
| NCT ID | NCT04526431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Kidney Transplant Failure and Rejection |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2020-07-28 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2020-07-28 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Thomas JOUVE, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Grenoble
Frequently Asked Questions
Who can join the NCT04526431 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Transplant Failure and Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04526431 currently recruiting?
Yes, NCT04526431 is actively recruiting participants. Contact the research team at tjouve@chu-grenoble.fr for enrollment information.
Where is the NCT04526431 trial being conducted?
This trial is being conducted at Grenoble, France, Saint-Etienne, France.
Who is sponsoring the NCT04526431 clinical trial?
NCT04526431 is sponsored by University Hospital, Grenoble. The principal investigator is Thomas JOUVE, MD, PhD at University Hospital, Grenoble. The trial plans to enroll 180 participants.
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