Overview

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.
Phase:
Phase 3
Details
Lead Sponsor:
Astellas Pharma Inc
Treatments:
Tacrolimus