Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients

Rennes University Hospital48 enrolled

Overview

The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.

The study will evaluate whether the blood concentration of TAC metabolites (13-O-desmethyl-tacrolimus, 15-O-desmethyl-tacrolimus and 31-O-desmethyl-tacrolimus), measured between Day1 and Day5 of its introduction, is increased in patients with TAC toxicity. A blood test will be performed daily from Day1 to Day5 for the measurement of TAC concentration and TAC metabolites concentration.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Concentration of Tacrolimus Metabolites

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (\> 18 years) of both sexes, * Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease, * Not having expressed their opposition to participation in the study Exclusion Criteria: * Associated transplantation of another organ * Contraindications to TAC administration * Delayed introduction of TAC (beyond the 5th postoperative day) whatever the cause.

Locations (1)

CHU Rennes

Rennes, France

RECRUITING

Outcomes

Primary Outcomes

Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not.

Time frame: Day 5

Central Contacts

Michel RAYAR, MD-PhD

CONTACT

299288498 michel.rayar@chu-rennes.fr

Data from ClinicalTrials.gov

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