Immunosuppressive Therapy Optimization: Development of a Population Pharmacokinetic-pharmacodynamic (PK-PD) Model in Liver Transplantation

Rennes University Hospital110 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

110

Conditions

Liver Transplantation

Interventions

Pharmacokinetic-pharmacodynamic model in liver transplantationOTHER

Biological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

CHU de Rennes

Rennes, France

Outcomes

Primary Outcomes

Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

Assessement of the relationships between tacrolimus dosage, whole-blood and intracellular concentrations

Time frame: Week 24

Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

Assessement of the relationships between intracellular concentrations of tacrolimus and calcineurin activity

Time frame: Week 24

Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

Assessement of the relationships between donor and recipient CYP3A5 and ABCB1 genotypes and dose/concentration of tacrolimus

Time frame: Week 24

Prediction of calcineurin inhibition, responsible for the immunosuppressive effect

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

Time frame: Week 24

Secondary Outcomes

Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration

Time frame: Week 24

Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR)

Time frame: Week 24

Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release)

Time frame: Week 24

Data from ClinicalTrials.gov

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