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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation
• Intervention / Treatment: Drug: Prograf; Drug: FK506MR capsule

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 Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjing, China
  • Beijing
    • Beijing, Beijing, China
  • Guangdong
    • Guangzhou, Guangdong, China
  • Liaoning
    • Shenyang, Liaoning, China
  • Shanghai
    • Shanghai, Shanghai, China
  • Zhejiang
    • Hangzhou, Zhejiang, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Drug: FK506MR capsule; Oral; Other Names: Advagraf; MR4; Prograf XL; tacrolimus modified release capsule
Active Comparator: 1	Drug: Prograf; Oral; Other Names: FK506; tacrolimus

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: January 23, 2008
• First Submitted That Met QC Criteria: February 7, 2008
• First Posted (Estimate): February 21, 2008

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Liver transplantation; prograf; FK506; tacrolimus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: MR4LTxCN02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED