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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.

Exclusion Criteria:

• Patients receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation).

• Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.

• Patients with serum creatinine > 200 µmol/l..