Clinical Trial

Tacrolimus Pharmacokinetic Subpopulations

Study acronym: TIPS
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 10, 2021 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2020-08-24.
Trial Details
NCT Number NCT04526431
Lead Sponsor University Hospital, Grenoble
Collaborators: Chiesi SA/NV
Conditions Kidney Transplant Failure and Rejection, Immunosuppression-related Infectious Disease
Enrollment 180 participants
Start Date 2020-07-28
Primary Completion 2026-08-01 (estimated)
Study Completion 2027-08-01 (estimated)
Updated on ClinicalTrials.gov 2021-02-10