Pharmacogenetic Study of Tacrolimus in Hepatic Transplant (CYPTAC'H)
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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Impact of Donor and Recipient CYP3A5 Genetic Polymorphism on Tacrolimus Exposure in Patients With Hepatic Transplant|
- Exposure to tacrolimus after the first administration, using tacrolimus area under curve (AUC) between 0 and 12 hours, weighted by the dose administered. [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
- Pharmacokinetics after the first administration and after 7 days of treatment [ Time Frame: 7 days ] [ Designated as safety issue: No ]Maximal concentration, time needed to reach maximal concentration, residual concentration 12 hours after drug administration, terminal elimination half-life, systemic clearance, AUC 0-12h/dose.
- Clinical follow-up during the 3 months post transplantation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Prescribed tacrolimus dose, tolerance of tacrolimus (hypertension, diabetes, renal insufficiency, neurological troubles) and signs of liver rejection assessed at each follow-up visit.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
|Experimental: Tacrolimus pharmacokinetics||
Other: Tacrolimus pharmacokinetics
tacrolimus pharmacokinetics over 12 hours
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388387
|Contact: Eric BELLISSANT, MD, PhD||+33299283715||Eric.Bellissant@univ-rennes1.fr|
|Contact: Marie-Clémence VERDIER, PharmDfirstname.lastname@example.org|
|Service des Maladies du Foie - Hôpital de Pontchaillou||Recruiting|
|Rennes, France, 35033|
|Contact: Marianne LATOURNERIE, MD email@example.com|
|Principal Investigator: Eric BELLISSANT, MD, PhD|
|Sub-Investigator: Christophe CAMUS, MD|
|Sub-Investigator: Marianne LATOURNERIE, MD|
|Sub-Investigator: Edouard BARDOU-JACQUET, MD|
|Sub-Investigator: Karim BOUDJEMA, MD, PhD|
|Study Chair:||Eric BELLISSANT, MD, PhD||Rennes University Hospital|
|Study Chair:||Marie-Clémence VERDIER, PharmD||Rennes University Hospital|