Pharmacogenetic Study of Tacrolimus in Hepatic Transplant (CYPTAC'H)
Impact of Donor and Recipient CYP3A5 Genetic Polymorphism on Tacrolimus Exposure in Patients With Hepatic Transplant
2 other identifiers
interventional
154
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 6, 2011
CompletedStudy Start
First participant enrolled
February 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2018
CompletedMay 24, 2023
May 1, 2023
6.4 years
July 1, 2011
May 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exposure to tacrolimus after the first administration, using tacrolimus area under curve (AUC) between 0 and 12 hours, weighted by the dose administered.
12 hours
Secondary Outcomes (2)
Pharmacokinetics after the first administration and after 7 days of treatment
7 days
Clinical follow-up during the 3 months post transplantation
3 months
Study Arms (1)
Tacrolimus pharmacokinetics
EXPERIMENTALInterventions
tacrolimus pharmacokinetics over 12 hours
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service des Maladies du Foie - Hôpital de Pontchaillou
Rennes, 35033, France
Related Publications (1)
Tron C, Woillard JB, Houssel-Debry P, David V, Jezequel C, Rayar M, Balakirouchenane D, Blanchet B, Debord J, Petitcollin A, Roussel M, Verdier MC, Bellissant E, Lemaitre F. Pharmacogenetic-Whole blood and intracellular pharmacokinetic-Pharmacodynamic (PG-PK2-PD) relationship of tacrolimus in liver transplant recipients. PLoS One. 2020 Mar 12;15(3):e0230195. doi: 10.1371/journal.pone.0230195. eCollection 2020.
PMID: 32163483RESULT
Study Officials
- STUDY CHAIR
Eric BELLISSANT, MD, PhD
Rennes University Hospital
- STUDY CHAIR
Marie-Clémence VERDIER, PharmD
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2011
First Posted
July 6, 2011
Study Start
February 22, 2012
Primary Completion
July 31, 2018
Study Completion
July 31, 2018
Last Updated
May 24, 2023
Record last verified: 2023-05