Tacrolimus Pharmacokinetic Subpopulations
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dosage Forms Oral
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Grenoble
Lead sponsor
Chiesi SA/NV
Collaborator
Source ClinicalTrials.gov