A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/ Myfortic® and Advagraf® (Extended Release Tacrolimus) / Myfortic® in de Novo Liver Transplant Recipients

To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.

Inclusion Criteria:

• Patient is a primary liver transplant recipient
• Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
• Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
• Patient must receive 1st dose of study drug within 24 hours of pre-transplantation

Exclusion Criteria:

• Patient has previously received or is receiving an organ transplant other than a liver
• Patient currently requires dialysis
• Patient has received a liver transplant from a non-heart beating donor
• Patient has received an ABO incompatible donor liver
• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
• Patient has fulminant hepatic failure, unless hemodynamically stable
• Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
• Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
• Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids
• Patient is pregnant or lactating