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โ† Trials
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Tacrolimus Pharmacokinetic Subpopulations

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Grenoble
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In plain words

What the trial is, and whether it could suit you

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 ยตg/l/mg) and other patients. The primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either \< or \>= 1.04 ยตg/l/mg, in order to detect differences in tacrolimus metabolization between these groups.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Dosage Forms Oral
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Where

2 sites
Grenoble University Hospital
Grenoble, France
Saint Etienne University Hospital
Saint-Etienne, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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