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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00459719
First Posted: April 12, 2007
Last Update Posted: February 24, 2016
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose

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
oral
Other Names:
  • Advagraf
  • FK506MR
  • MR4
Active Comparator: 2
In combination with steroids
Drug: Prograf
oral
Other Names:
  • tacrolimus
  • FK506

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00459719


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

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00459719     History of Changes
Other Study ID Numbers: MR4LTxCN01
First Submitted: April 10, 2007
First Posted: April 12, 2007
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
Tacrolimus
Methylprednisolone
Prednisolone

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action