Actively Recruiting
Tacrolimus Pharmacokinetic Subpopulations
Led by University Hospital, Grenoble · Updated on 2021-02-10
180
Participants Needed
2
Research Sites
365 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Grenoble
Lead Sponsor
C
Chiesi SA/NV
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tacrolimus Pharmacokinetic Subpopulations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Kidney transplant patients at the CHUGA, CHU Saint-Etienne or CHU Clermont-Ferrand, with a transplant no more than 7 days old
- Patients initially treated with tacrolimus combined with mycophenolate, mycophenolic acid, or everolimus, with or without corticotherapy
- No plans to stop tacrolimus treatment during the first 4 years post-transplant
- Affiliated with or beneficiary of a social security scheme
- Able to read and understand the study protocol
- Informed consent obtained, including for genetic analysis
- For women of childbearing potential, effective contraception is required if treated with mycophenolic acid
You will not qualify if you...
- Contraindication to tacrolimus use
- Already treated with tacrolimus at the time of transplantation
- Pregnant, parturient, or breastfeeding women
- Patients deprived of liberty by judicial or administrative decision
- Patients under guardianship, curatorship, or forced psychiatric care
- Persons admitted to a health or social institution
- Subjects who cannot be contacted in case of emergency
- Subjects currently excluded from another study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Grenoble University Hospital
Grenoble, Auvergne-Rhône-Alpes, France, 38043
Actively Recruiting
2
Saint Etienne University Hospital
Saint-Etienne, Auvergne-Rhône-Alpes, France, 42000
Not Yet Recruiting
Research Team
T
Thomas JOUVE, MD, PhD
CONTACT
J
Johan NOBLE, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here