A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients
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This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.
Condition or disease
Drug: PrografDrug: FK506MR capsule
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)