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

A multicentre, randomized, open label, two parallel group study The patients will be randomized to MR4 group or Prograf® group. The treatment period is 3 months( 12 weeks).Patients randomized to MR4 group who complete 3 months treatment period will continue to use MR4 until MR4 commercial available or authority notification.

Inclusion criteria

• Written informed consent with the date of the patient must be obtained
• Patient is the recipient of a liver transplant from 6 to 24 months prior to enrollment
• Patient is currently receiving Prograf or Prograf + MMF based immunosuppressive therapy
• At screening the liver and kidney function of patient is stable (defined as Serum creatinine is normal and ALT or AST is <= 2 times the upper value of normal range)
• Patient has the stable whole blood trough level concentration of Prograf (defined as tacrolimus trough concentrations of 2-10ng/ml measured 14 days prior to enrollment), and is clinically stable in the opinion of the investigator

Exclusion criteria

• Patient has received an organ transplant other than a kidney
• Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy
• Patient is currently receiving other immunosuppressant therapy, eg. sirolimus
• Patient with liver recurrent cancer, or metastasis, or other cancer
• Patient has any unstable medical condition that could interfere with the study objectives
• Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment
• Patient is allergic macrolide antibiotics or tacrolimus
• Patient has psychiatric disorder, in the opinion of the investigator, may invalidate communication with the investigator
• Patient is currently receiving any medications, which is know to alter the CYP450 3A enzyme system (including grapefruit juice)