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

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ClinicalTrials.gov Identifier: NCT01018914
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : January 29, 2016
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

November 23, 2009
November 25, 2009
January 29, 2016
April 2009
December 2010   (Final data collection date for primary outcome measure)
Incidence of biopsy confirmed acute rejection [ Time Frame: during the 6 months post-transplant. ]
Same as current
Complete list of historical versions of study NCT01018914 on ClinicalTrials.gov Archive Site
  • Patient and graft survival rates [ Time Frame: during the 6 months post-transplant ]
  • Time to first biopsy confirmed acute rejection episode [ Time Frame: during the 6 months post-transplant ]
  • Incidence of anti-lymphocyte antibody therapy for treatment of rejection [ Time Frame: during the 6 months post-transplant. ]
  • Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs [ Time Frame: throughout the study ]
Same as current
Not Provided
Not Provided
 
A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients
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
To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Liver Transplantation
  • Drug: Prograf
    oral
    Other Names:
    • Tacrolimus
    • FK506
  • Drug: Advagraf
    oral
    Other Names:
    • Extended release tacrolimus
    • FK506E
    • MR4
  • Drug: Myfortic
    oral
    Other Name: Mycophenolate sodium
  • Active Comparator: Prograf with Myfortic
    Interventions:
    • Drug: Prograf
    • Drug: Myfortic
  • Experimental: Advagraf with Myfortic
    Interventions:
    • Drug: Advagraf
    • Drug: Myfortic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
40
December 2010
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01018914
ADVLTx-0901-TW
No
Not Provided
Plan to Share IPD: Undecided
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP