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

NCT ID: NCT00619398

Last Updated: 2016-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-03-31

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.

Conditions

Liver Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Prograf

Intervention Type: DRUG

Oral

2

Group Type: EXPERIMENTAL

FK506MR capsule

Intervention Type: DRUG

Oral

Interventions

Prograf

Oral

Intervention Type: DRUG

FK506MR capsule

Oral

Intervention Type: DRUG

Other Intervention Names

tacrolimus; FK506; Advagraf; tacrolimus modified release capsule; MR4; Prograf XL

Eligibility Criteria

Inclusion Criteria

1. Written informed consent with the date of the patient must be obtained

2. Patient is the recipient of a liver transplant from 6 to 24 months prior to enrollment

3. Patient is currently receiving Prograf or Prograf + MMF based immunosuppressive therapy

4. 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)

5. 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

1. Patient has received an organ transplant other than a kidney

2. 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

3. Patient is currently receiving other immunosuppressant therapy, eg. sirolimus

4. Patient with liver recurrent cancer, or metastasis, or other cancer

5. Patient has any unstable medical condition that could interfere with the study objectives

6. 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

7. Patient is allergic macrolide antibiotics or tacrolimus

8. Patient has psychiatric disorder, in the opinion of the investigator, may invalidate communication with the investigator

9. Patient is currently receiving any medications, which is know to alter the CYP450 3A enzyme system (including grapefruit juice)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

Beijing, Beijing Municipality, China

Guangzhou, Guangdong, China

Shenyang, Liaoning, China

Shanghai, Shanghai Municipality, China

Hangzhou, Zhejiang, China

Tianjing, , China

Countries

China

Other Identifiers

MR4LTxCN02

Identifier Type: -

Identifier Source: org_study_id