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

NCT ID: NCT05277792

Last Updated: 2023-07-28

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

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-08

Study Completion Date

2024-06-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Blood Concentration of Tacrolimus Metabolites

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
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 Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Michel RAYAR, MD-PhD

Role: CONTACT

299288498 ext. +33

Facility Contacts

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Michel RAYAR, MD-PhD

Role: primary

299288498 ext. +33

Other Identifiers

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35RC20_8890_STABILE 2

Identifier Type: -

Identifier Source: org_study_id

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