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Trial record 1 of 1 for:    NCT00459719
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A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459719
Recruitment Status : Completed
First Posted : April 12, 2007
Last Update Posted : February 24, 2016
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:

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 or disease Intervention/treatment Phase
Liver Transplantation Drug: Tacrolimus modified-release Drug: Prograf Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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.
Study Start Date : March 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459719

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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
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Principal Investigator: Prof. Leng Xisheng Department of Hepatobiliary surgery
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Responsible Party: Astellas Pharma Inc Identifier: NCT00459719    
Other Study ID Numbers: MR4LTxCN01
First Posted: April 12, 2007    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc:
Liver Transplantation
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action