Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
Recruiting
- Conditions
- Blood Concentration of Tacrolimus Metabolites
- Registration Number
- NCT05277792
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
The purpose of this study is to evaluate if concentration of tacrolimus metabolites is increased in patients presenting tacrolimus (TAC) side effects.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not. Day 5
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU Rennes
🇫🇷Rennes, France