Pharmacogenetic Study of Tacrolimus in Hepatic Transplant (CYPTAC'H)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-22

Study Completion Date

2018-07-31

Brief Summary

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The choice of an immunosuppressant after hepatic transplant is now more difficult than before because of the increasing number of drugs available.

Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best treatment and the best dose for each patient. The genetic polymorphism of enzymes metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5 activity is a major determinant of the dose needed to reach target concentrations. This study is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic polymorphisms on tacrolimus exposure in patients with hepatic transplant.

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Detailed Description

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Pharmacogenetics is a recent tool which could help to choose the best immunosuppressive therapy in patients with hepatic transplant. Indeed, the CYP3A5 gene has many polymorphisms and one of them, g.6986 A\>G, is the major determinant of the variability of expression of this protein. The allele \*1 (g6986A) leads to normal protein expression while the allele \*3 (g.6986G) causes lack of protein expression, and their different combinations induce a great variability in tacrolimus concentrations. As cytochromes are present in the liver and intestine, in hepatic transplant, tacrolimus exposure results from both recipient (enterocytes) and donor (liver) enzymes. Recent studies demonstrated a significant role of the genotype recipient on the dose/concentration relationship and on the dose needed to reach target concentrations. However, these studies were insufficient to analyze more precisely all impacts of this polymorphism because they did not include enough patients. The purpose of the investigators study is to evaluate the impact of donor and recipient CYP3A5 genetic polymorphism on tacrolimus exposure in patients with hepatic transplant after the first administration of tacrolimus and at 7 days post transplantation, when the dose has been adapted to avoid too high blood levels and to limit serious adverse reactions.

Conditions

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Hepatic Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tacrolimus pharmacokinetics

Group Type EXPERIMENTAL

Tacrolimus pharmacokinetics

Intervention Type OTHER

tacrolimus pharmacokinetics over 12 hours

Interventions

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Tacrolimus pharmacokinetics

tacrolimus pharmacokinetics over 12 hours

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults (\>18 years) of Caucasian origin,
* with hepatic transplant,
* who are going to be treated by tacrolimus, and
* who gave free, well-informed and written consent.

* Participation to another protocol incompatible with the study,
* HIV patients with antiretroviral treatment,
* Patients with legal guardianship or deprived of freedom.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No