Status:
COMPLETED
A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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® ...
Detailed Description
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 g...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00619398
Start Date
January 1 2008
End Date
March 1 2009
Last Update
February 24 2016
Active Locations (6)
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1
Beijing, Beijing Municipality, China
2
Guangzhou, Guangdong, China
3
Shenyang, Liaoning, China
4
Shanghai, Shanghai Municipality, China