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Tacrolimus Pharmacokinetic Subpopulations

NCT04526431 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2021-02-10

No results posted yet for this study

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.

Conditions

  • Kidney Transplant Failure and Rejection
  • Immunosuppression-related Infectious Disease

Interventions

DRUG

Dosage Forms Oral

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

Sponsors & Collaborators

  • Chiesi SA/NV

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Thomas JOUVE, MD, PhD · University Hospital, Grenoble

  • Lionel ROSTAING, MD, PhD · University Hospital, Grenoble

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2026-08-01
Completion
2027-08-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04526431 on ClinicalTrials.gov