NCT00189826

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 475 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver 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 dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen.

Conditions

• Liver 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

51 sites across 16 countries: Australia, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Ireland, Italy, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom