Investigating tacrolimus metabolism in kidney transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inducing immunological tolerance in kidney transplant patients using stem cell infusion

  This study is testing whether giving stem cells from the same donor to kidney transplant patients can help them stop taking their immunosuppressive medications safely.

  Recruiting Phase 1 University of California, Los Angeles · Los Angeles, California · NCT05525507

• Treating BK Virus Infections in Kidney Transplant Recipients

  This study is testing if changing the way we manage immune suppression and giving a special treatment can help kidney transplant patients with BK virus infections feel better and keep their transplants healthy.

  Recruiting at 13 sites Phase 3 The University of Queensland · Canberra, Australian Capital Territory and 12 other locations · NCT05325008

• Using Everolimus to Treat Kidney Transplant Patients with Unique Rejection Issues

  This study is testing if the drug Everolimus can help kidney transplant patients who have a specific type of rejection that isn't well understood, to see if it improves their kidney function and overall health.

  Recruiting Hospices Civils de Lyon · Lyon · NCT03955172

• Belimumab to mobilize memory B cells to help delistings for highly sensitized kidney transplant candidates

  A short belimumab course is being tested to see if it can reveal memory B cells that target donor HLAs, helping to decide which donors to exclude and potentially speed up getting a transplant for highly sensitized patients.

  Recruiting Phase 2 Leiden University Medical Center · Leiden · NCT07539857

• Frexalimab versus tacrolimus to prevent kidney transplant rejection

  This trial will test whether frexalimab injections given for up to five years work as well and are as safe as tacrolimus capsules at preventing rejection in adults getting their first kidney transplant who have low-to-moderate immune risk.

  Recruiting at 73 sites Phase 2/3 Sanofi · San Francisco, California and 72 other locations · NCT07412470

• Platelet aggregation for diagnosing acute kidney transplant rejection

  This study will test whether changes in platelet activation measured from blood can help detect acute rejection in adult kidney transplant recipients.

  Recruiting University Hospital, Martin · Martin · NCT07275541

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.