A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1
|
Drug: Prograf
Oral
Other Names:
|
| Experimental: 2
|
Drug: FK506MR capsule
Oral
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Event rate of patients with acute rejections [12 Weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing | Beijing | China | ||
| 2 | Guangzhou | Guangdong | China | ||
| 3 | Shenyang | Liaoning | China | ||
| 4 | Shanghai | Shanghai | China | ||
| 5 | Hangzhou | Zhejiang | China | ||
| 6 | Tianjing | China |
Sponsors and Collaborators
- Astellas Pharma Inc
Investigators
- Study Chair: Central Contact, Astellas Pharma Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MR4LTxCN02