Investigating tacrolimus metabolism in kidney transplant patients
Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C/D Ratio
This study looks at how kidney transplant patients process a medication called tacrolimus over four years to see if it affects their kidney health and how genetics might play a role.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 2 sites (Grenoble, Auvergne-Rhône-Alpes and 1 other locations) |
| Trial ID | NCT04526431 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the concentrations of tacrolimus metabolites in kidney transplant patients over the first four years post-transplantation. It will compare the concentration-to-dose ratio (C/D ratio) of tacrolimus metabolites between patients classified as 'high rate metabolizers' and others to understand the impact on kidney graft survival. The study will also explore the genetic factors influencing tacrolimus metabolism and how different formulations of the drug may affect pharmacokinetics. By identifying metabolism patterns, the study seeks to improve immunosuppressive strategies for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include kidney transplant patients within 7 days of their transplant who are being treated with tacrolimus as part of their immunosuppressive regimen.
Not a fit: Patients who have contraindications to tacrolimus or are already being treated with it prior to the study will not benefit from this research.
Why it matters
Potential benefit: If successful, this study could lead to improved management of tacrolimus therapy, enhancing kidney transplant survival rates.
How similar studies have performed: Previous studies have indicated a relationship between tacrolimus concentration and graft survival, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Grenoble, Auvergne-Rhône-Alpes and 1 other locations
- Grenoble University Hospital — Grenoble, Auvergne-Rhône-Alpes, France (Recruiting)
- Saint Etienne University Hospital — Saint-Etienne, Auvergne-Rhône-Alpes, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Thomas JOUVE, MD, PhD — University Hospital, Grenoble
- Study coordinator: Thomas JOUVE, MD, PhD
- Email: tjouve@chu-grenoble.fr
- Phone: +33476765460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.