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NCT02877628 Clinical Trial

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

Liver Transplantation Clinical Trial

— OPTILTH  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02877628
Other study ID # 35RC13_8962_OPTILTH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 31, 2015
Est. completion date December 2018

Study information
Verified date January 2019
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date December 2018
Est. primary completion date November 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Pharmacokinetic-pharmacodynamic model in liver transplantation
Biological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination

Locations
Country Name City State
France CHU de Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediction of calcineurin inhibition, responsible for the immunosuppressive effect Assessement of the relationships between tacrolimus dosage, whole-blood and intracellular concentrations Week 24
Primary Prediction of calcineurin inhibition, responsible for the immunosuppressive effect Assessement of the relationships between intracellular concentrations of tacrolimus and calcineurin activity Week 24
Primary 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
Primary 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
Secondary Study of impact of pharmacogenetic and demographic data on tacrolimus intracellular concentration Week 24
Secondary Evaluation of the role of the measurement of intracellular concentration as a longitudinal biomarker in preventing acute cellular graft (ACR) Week 24
Secondary Study of variability of tacrolimus intracellular concentration according to its pharmaceutic form (immediate or sustained release) Week 24
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