Tacrolimus Pharmacokinetic Subpopulations
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 concen
| Condition(s) | Kidney Transplant Failure and Rejection, Immunosuppression-related Infectious Disease |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 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. |
| Who can participate | 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 contr |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Grenoble |
| Locations | Grenoble, Auvergne-Rhône-Alpes, France; Saint-Etienne, Auvergne-Rhône-Alpes, France |
| Start date | 2020-07-28 |
| NCT ID | NCT04526431 |
| Official listing | https://clinicaltrials.gov/study/NCT04526431 |