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

Information source: Rennes University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatic Transplantation

Intervention: Tacrolimus pharmacokinetics (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Rennes University Hospital

Official(s) and/or principal investigator(s):
Eric BELLISSANT, MD, PhD, Study Chair, Affiliation: Rennes University Hospital
Marie-Clémence VERDIER, PharmD, Study Chair, Affiliation: Rennes University Hospital

Overall contact:
Eric BELLISSANT, MD, PhD, Phone: +33299283715, Email: Eric.Bellissant@univ-rennes1.fr

Summary

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.

Clinical Details

Official title: Impact of Donor and Recipient CYP3A5 Genetic Polymorphism on Tacrolimus Exposure in Patients With Hepatic Transplant

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Exposure to tacrolimus after the first administration, using tacrolimus area under curve (AUC) between 0 and 12 hours, weighted by the dose administered.

Secondary outcome:

Pharmacokinetics after the first administration and after 7 days of treatment

Clinical follow-up during the 3 months post transplantation

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Non-inclusion Criteria:

- Participation to another protocol incompatible with the study,

- HIV patients with antiretroviral treatment,

- Patients with legal guardianship or deprived of freedom.

Locations and Contacts

Eric BELLISSANT, MD, PhD, Phone: +33299283715, Email: Eric.Bellissant@univ-rennes1.fr

Service des Maladies du Foie - Hôpital de Pontchaillou, Rennes 35033, France; Recruiting
Marianne LATOURNERIE, MD, Email: marianne.latournerie@chu-rennes.fr
Eric BELLISSANT, MD, PhD, Principal Investigator
Christophe CAMUS, MD, Sub-Investigator
Marianne LATOURNERIE, MD, Sub-Investigator
Edouard BARDOU-JACQUET, MD, Sub-Investigator
Karim BOUDJEMA, MD, PhD, Sub-Investigator
Additional Information

Starting date: January 2012
Last updated: August 20, 2015

Page last updated: August 20, 2015

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