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

NCT ID: NCT02877628

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Pharmacokinetic-pharmacodynamic model in liver transplantation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC13_8962_OPTILTH

Identifier Type: -

Identifier Source: org_study_id

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