A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation
Phase 3
Completed
- Conditions
- Liver Transplantation
- Interventions
- Registration Number
- NCT00459719
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The patients about to undergo liver transplantation will be randomized to one of the following two group:
Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Written informed consent with the date of the patient must be obtained.
- Patient between 18-70 years of age receiving the primary liver.
- Female patients must have a negative pregnancy test prior to the enrolment.
- Female patients of child bearing potential must agree to practice effective birth control during the study
Exclusion Criteria
- Liver re-transplantation patients or received an organ transplantation other than a liver.
- Living-related liver transplantation patient.
- Patient has received an AB0 incompatible donor liver.
- Patient who needs antibody induction therapy.
- Patient with sever infection requiring treatment.
- Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Prograf In combination with steroids 1 Tacrolimus modified-release In combination with steroids
- Primary Outcome Measures
Name Time Method Event rate of patients with acute rejections 12 Weeks
- Secondary Outcome Measures
Name Time Method Incidence of and time to acute rejections 12 Weeks Overall frequency of acute rejections 12 Weeks Rate of patient and graft survival following transplantation. 12 weeks