drugset / Trial / NCT02311010

Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism

NCT02311010 ↗

Phase 4 Unknown 150 enrolled Catholic University of Louvain
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-01
Primary completion
2014-10
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule 0.2 mg/kg —
Comparator Tacrolimus Small molecule 0.25 mg/kg —
Comparator Tacrolimus Small molecule 0.3 mg/kg —
Comparator Tacrolimus Small molecule 0.35 mg/kg —

Indications