Status:
RECRUITING
Tacrolimus Pharmacokinetic Subpopulations
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Chiesi SA/NV
Conditions:
Kidney Transplant Failure and Rejection
Immunosuppression-related Infectious Disease
Eligibility:
All Genders
18+ years
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 differen...
Detailed Description
Tacrolimus is the cornerstone of immunosuppression in renal transplantation, but its nephrotoxicity, in particular, makes it a drug with a narrow therapeutic range, requiring regular pharmacokinetic m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04526431
Start Date
July 28 2020
End Date
August 1 2027
Last Update
February 10 2021
Active Locations (2)
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1
Grenoble University Hospital
Grenoble, Auvergne-Rhône-Alpes, France, 38043
2
Saint Etienne University Hospital
Saint-Etienne, Auvergne-Rhône-Alpes, France, 42000