Overview

This trial is active, not recruiting.

Condition kidney diseases
Treatment advagraf
Phase phase 4
Sponsor Université Catholique de Louvain
Start date January 2011
End date October 2014
Trial size 150 participants
Trial identifier NCT02311010, 2011-004276-11, BE-02-RG-234

Summary

To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient.

The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
CYP 3 A 5 *3/*3 control group will receive 0,20 mg/kg of Advagraf®
(Active Comparator)
CYP 3 A 5 *3/*3 will receive 0,25 mg/kg of Advagraf®
advagraf Tacrolimus prolonged release formulation
daily dose adapted according to Cyp 3A5 polymorphism
(Active Comparator)
CYP 3 A 5 *1/*3 will receive 0,30 mg/kg of Advagraf®
advagraf Tacrolimus prolonged release formulation
daily dose adapted according to Cyp 3A5 polymorphism
(Active Comparator)
CYP 3 A 5 *1/*1 will receive 0,35 mg/kg of Advagraf®
advagraf Tacrolimus prolonged release formulation
daily dose adapted according to Cyp 3A5 polymorphism

Primary Outcomes

Measure
Pharmacokinetics of tacrolimus
time frame: 1 year

Secondary Outcomes

Measure
Kidney graft function
time frame: 1 year

Eligibility Criteria

Male or female participants from 15 years up to 70 years old.

Inclusion Criteria: - First or second Kidney Transplantation from deceased or living donor Exclusion Criteria: - Donor age < 5 years. - Patients who require plasma exchange because of high immunological risk

Additional Information

Official title Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Université Catholique de Louvain.