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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacokinetic-pharmacodynamic model in liver transplantation | Other | Biological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination |
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of calcineurin inhibition, responsible for the immunosuppressive effect | Assessement of the relationships between tacrolimus dosage, whole-blood and intracellular concentrations | Week 24 |
| Prediction of calcineurin inhibition, responsible for the immunosuppressive effect | Assessement of the relationships between intracellular concentrations of tacrolimus and calcineurin activity | 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 | 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 | Week 24 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with liver tranplantation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Rennes | Rennes | 35033 | France |
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| Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release) | Week 24 |
| ID | Term |
|---|---|
| D016031 | Liver Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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