Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)
Completed
- Conditions
- Biliary Concentration of Tacrolimus
- Registration Number
- NCT02820259
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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
- Bilio-enteric anastomosis,
- Associated transplantation of another organ
- Contraindications to TCR administration
- Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method coefficient of correlation (r²) between the biliary concentration of TCR and concentration within PBMC during the first 7 days after its initiation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre hospitalier universitaire de Rennes
🇫🇷Rennes, France