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Tacrolimus Pharmacokinetic Subpopulations
Sponsor: University Hospital, Grenoble
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
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