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

Study Overview
=================
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® with regards to the efficacy and safety.

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 group who complete 3 months treatment period will continue to use MR4 until MR4 commercial available or authority notification.

Official Title
-----------------
A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients and a Pharmacokinetics Study

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Drug: Prograf
* Drug: FK506MR capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Prograf<br>* Oral<br>* Other names: FK506;|
| Experimental: 2<br> | Drug: FK506MR capsule<br>* Oral<br>* Other names: Prograf XL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of patients with acute rejections |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of and time to acute rejections |  | 12 Weeks | 
| Overall frequency of acute rejections |  | 12 Weeks | 
| Rate of patients and graft survival following transplantation |  | 12 Weeks | 
| Incidence of adverse events including laboratory assessments |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FK506, tacrolimus, prograf, Liver transplantation