Liver Transplantation
Conditions
Keywords
pharmacokinetic, pharmacodynamic, tacrolimus, CYP3A5, liver transplantation
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.
Interventions
OTHERPharmacokinetic-pharmacodynamic model in liver transplantation
Biological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination
Sponsors
Rennes University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of calcineurin inhibition, responsible for the immunosuppressive effect | Week 24 | Assessement of the relationships between tacrolimus dosage, whole-blood and intracellular concentrations |
Secondary
| Measure | Time frame |
|---|---|
| Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration | 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 variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release) | Week 24 |
Countries
France
Outcome results
None listed