Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation
Completed
- Conditions
- Liver Transplantation
- Registration Number
- NCT02877628
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
Prospective, non-randomized, open Pharmacokinetic-Pharmacogenetic-Pharmacodynamic monocentric study. Donor and recipient CYP3A5 genotype and recipient ABCB1 will not be communicate to clinicians or patients during the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
- Adults over 18
- Liver transplant recipients
- Treated with an immunosuppressive protocol with tacrolimus
- Informed on the study and who did not refuse to participate
Exclusion Criteria
- Patients who participate in a study with procedures incompatible with the present study.
- Patients with legal protection/deprived of liberty.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prediction of calcineurin inhibition, responsible for the immunosuppressive effect Week 24 Assessement of the relationships between intracellular concentration of tacrolimus and/or calcineurin activity and ACR, in patients treated with immediate release or modified-release formulation of tacrolimus
- Secondary Outcome Measures
Name Time Method Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release) Week 24 Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR) Week 24 Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration Week 24
Trial Locations
- Locations (1)
CHU de Rennes
🇫🇷Rennes, France