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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00459719
Collaborator
(none)
42
Enrollment
5
Locations
2
Arms
24
Duration (Months)
8.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Mar 1, 2007
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Event rate of patients with acute rejections [12 Weeks]

    Secondary Outcome Measures

    1. Incidence of and time to acute rejections [12 Weeks]

    2. Overall frequency of acute rejections [12 Weeks]

    3. Rate of patient and graft survival following transplantation. [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    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

    Locations

    Site City State Country Postal Code
    1 Beijing Beijing China
    2 Guangzhou Guangdong China
    3 Shanghai Shanghai China
    4 Hangzhou Zhejiang China
    5 Tianjin China

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Principal Investigator: Prof. Leng Xisheng, Department of Hepatobiliary surgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT00459719
    Other Study ID Numbers:
    • MR4LTxCN01
    First Posted:
    Apr 12, 2007
    Last Update Posted:
    Feb 24, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Astellas Pharma Inc
    Liver Transplantation
    Tacrolimus
    Methylprednisolone
    Prednisolone
    Additional relevant MeSH terms:
    Tacrolimus

    Study Results

    No Results Posted as of Feb 24, 2016