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RECRUITING
NCT04526431

Tacrolimus Pharmacokinetic Subpopulations

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

Summary

This prospective study will investigate the concentrations of tacrolimus metabolites (M-I and M-III) over the four first years post-transplantation. A differential metabolism might result in different metabolites' concentration and explain a kidney survival difference between "high rate metabolism" (defined as a concentration/dose ratio, C/D ratio, lower than 1.04 µg/l/mg) and other patients. The primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either \< or \>= 1.04 µg/l/mg, in order to detect differences in tacrolimus metabolization between these groups.

Official title: Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C/D Ratio

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2020-07-28

Completion Date

2027-08-01

Last Updated

2021-02-10

Healthy Volunteers

No

Interventions

DRUG

Dosage Forms Oral

Dosage form of tacrolimus (extended release tacrolimus or immediate release tacrolimus)

Locations (2)

Grenoble University Hospital

Grenoble, Auvergne-Rhône-Alpes, France

Saint Etienne University Hospital

Saint-Etienne, Auvergne-Rhône-Alpes, France