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STABILE 2: Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients

Sponsor
Rennes University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277792
Collaborator
(none)
48
Enrollment
1
Location
11.8
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    48 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dosage of Tacrolimus Metabolites in Blood and Bile for Prediction of Its Side Effects in Liver Transplant Recipients
    Actual Study Start Date :
    May 8, 2022
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    May 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not. [Day 5]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Rennes Rennes France 35033

    Sponsors and Collaborators

    • Rennes University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rennes University Hospital
    ClinicalTrials.gov Identifier:
    NCT05277792
    Other Study ID Numbers:
    • 35RC20_8890_STABILE 2
    First Posted:
    Mar 14, 2022
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rennes University Hospital
    Tacrolimus, metabolites, liver transplantation

    Study Results

    No Results Posted as of Aug 22, 2022