Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05277792
Acronym
STABILE 2
Enrollment
48
Registered
2022-03-14
Start date
2022-05-08
Completion date
2024-06-08
Last updated
2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Concentration of Tacrolimus Metabolites

Keywords

Tacrolimus, metabolites, liver transplantation

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.

Interventions

None listed

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Comparison of blood concentration of TAC metabolites between patients presenting TAC related side effects or not.Day 5

Countries

France

Contacts

Primary ContactMichel RAYAR, MD-PhD
michel.rayar@chu-rennes.fr299288498

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026