Tacrolimus Pharmacokinetic Subpopulations

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Aug 24, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes a medication called tacrolimus, which is used to prevent rejection in kidney transplant patients. The researchers want to understand if some patients metabolize tacrolimus differently than others, particularly focusing on the levels of specific substances (metabolites) produced from it in the first four years after a transplant. By comparing these levels in patients who metabolize tacrolimus at different rates, the study aims to find out if this affects kidney survival after the transplant.

To be eligible for this study, participants must have received a kidney transplant within the last week and be treated with tacrolimus alongside other medications to help prevent rejection. They should not have plans to switch from tacrolimus in the following four years. The trial is open to all adults aged 65 to 74 who understand the study details and can provide consent. Participants will have their tacrolimus levels monitored over time, and those who join will help researchers learn more about the best ways to manage kidney transplant care.

Gender

ALL

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