A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.

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

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.