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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:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00459719
First received: April 10, 2007
Last updated: March 10, 2009
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Event rate of patients with acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459719

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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00459719     History of Changes
Other Study ID Numbers: MR4LTxCN01
Study First Received: April 10, 2007
Last Updated: March 10, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Liver Transplantation
Tacrolimus
Methylprednisolone
Prednisolone

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013