drugset / Trial / NCT02034747

A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients

NCT02034747 ↗

Phase 4 Completed 150 enrolled Astellas Pharma Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid. The eligible patients will be randomized into either Arm 1 or Arm 2. The Arm 1 will be reduced corticosteroid slowly until 50% lower dose from 4 weeks to 12 weeks in the Advagraf®-based immunosuppressive regimen, and the Arm 2 will receive the same corticosteroid dose for 24 weeks with Advagraf ®.

Timeline

Start
2013-11-21
Primary completion
2015-11-07
Completion
2015-11-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule — Oral

Indications

No indication recorded.