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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: April 10, 2007
Last updated: February 23, 2016
Last verified: February 2016

The patients about to undergo liver transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks

Condition Intervention Phase
Liver Transplantation Drug: Tacrolimus modified-release Drug: Prograf Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Event rate of patients with acute rejections [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • Incidence of and time to acute rejections [ Time Frame: 12 Weeks ]
  • Overall frequency of acute rejections [ Time Frame: 12 Weeks ]
  • Rate of patient and graft survival following transplantation. [ Time Frame: 12 weeks ]

Enrollment: 42
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
In combination with steroids
Drug: Tacrolimus modified-release
Other Names:
  • Advagraf
  • FK506MR
  • MR4
Active Comparator: 2
In combination with steroids
Drug: Prograf
Other Names:
  • tacrolimus
  • FK506


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent with the date of the patient must be obtained.
  • Patient between 18-70 years of age receiving the primary liver.
  • Female patients must have a negative pregnancy test prior to the enrolment.
  • Female patients of child bearing potential must agree to practice effective birth control during the study

Exclusion Criteria:

  • Liver re-transplantation patients or received an organ transplantation other than a liver.
  • Living-related liver transplantation patient.
  • Patient has received an AB0 incompatible donor liver.
  • Patient who needs antibody induction therapy.
  • Patient with sever infection requiring treatment.
  • Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00459719

China, Beijing
Beijing, Beijing, China
China, Guangdong
Guangzhou, Guangdong, China
China, Shanghai
Shanghai, Shanghai, China
China, Zhejiang
Hangzhou, Zhejiang, China
Tianjin, China
Sponsors and Collaborators
Astellas Pharma Inc
Principal Investigator: Prof. Leng Xisheng Department of Hepatobiliary surgery
  More Information

Responsible Party: Astellas Pharma Inc Identifier: NCT00459719     History of Changes
Other Study ID Numbers: MR4LTxCN01
Study First Received: April 10, 2007
Last Updated: February 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Liver Transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 18, 2017