NCT00189839

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

A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With MMF (Cellcept®) and Steroids in Patients Undergoing Kidney Transplantation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 699 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	tacrolimus	Immunosuppression

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-19
• Last updated: 2014-07-09

Locations

80 sites across 23 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom