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A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT01018914
Collaborator
Astellas Pharma Taiwan, Inc. (Industry)
44
Enrollment
3
Locations
2
Arms
20
Duration (Months)
14.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/ Myfortic® and Advagraf® (Extended Release Tacrolimus) / Myfortic® in de Novo Liver Transplant Recipients
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Prograf with Myfortic

Drug: Prograf
oral
Other Names:
  • Tacrolimus
  • FK506

    • Drug: Myfortic
    oral
    Other Names:
  • Mycophenolate sodium

    		•
    Experimental: Advagraf with Myfortic

    Drug: Advagraf
    oral
    Other Names:
  • Extended release tacrolimus
  • FK506E
  • MR4

    • Drug: Myfortic
    oral
    Other Names:
  • Mycophenolate sodium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of biopsy confirmed acute rejection [during the 6 months post-transplant.]

    Secondary Outcome Measures

    1. Patient and graft survival rates [during the 6 months post-transplant]

    2. Time to first biopsy confirmed acute rejection episode [during the 6 months post-transplant]

    3. Incidence of anti-lymphocyte antibody therapy for treatment of rejection [during the 6 months post-transplant.]

    4. Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs [throughout the study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient is a primary liver transplant recipient

    • Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant

    • Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures

    • Patient must receive 1st dose of study drug within 24 hours of pre-transplantation

    Exclusion Criteria:

    • Patient has previously received or is receiving an organ transplant other than a liver

    • Patient currently requires dialysis

    • Patient has received a liver transplant from a non-heart beating donor

    • Patient has received an ABO incompatible donor liver

    • Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)

    • Patient has fulminant hepatic failure, unless hemodynamically stable

    • Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives

    • Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant

    • Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids

    • Patient is pregnant or lactating

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taichung Taiwan
    2 Tainan Taiwan
    3 Taipei Taiwan

    Sponsors and Collaborators

    • Astellas Pharma Inc
    • Astellas Pharma Taiwan, Inc.

    Investigators

    • Study Chair: Use Central Contact, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT01018914
    Other Study ID Numbers:
    • ADVLTx-0901-TW
    First Posted:
    Nov 25, 2009
    Last Update Posted:
    Jan 29, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Astellas Pharma Inc
    Prograf
    Advagraf
    Myfortic
    Additional relevant MeSH terms:
    Mycophenolic Acid
    Tacrolimus

    Study Results

    No Results Posted as of Jan 29, 2016