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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01018914
First received: November 23, 2009
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Liver Transplantation
 Drug: Prograf
Drug: Advagraf
Drug: Myfortic
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of biopsy confirmed acute rejection [ Time Frame: during the 6 months post-transplant. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient and graft survival rates [ Time Frame: during the 6 months post-transplant ] [ Designated as safety issue: No ]
  • Time to first biopsy confirmed acute rejection episode [ Time Frame: during the 6 months post-transplant ] [ Designated as safety issue: No ]
  • Incidence of anti-lymphocyte antibody therapy for treatment of rejection [ Time Frame: during the 6 months post-transplant. ] [ Designated as safety issue: No ]
  • Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prograf with Myfortic Drug: Prograf
oral
Other Names:
  • Tacrolimus
  • FK506
Drug: Myfortic
oral
Other Name: Mycophenolate sodium
Experimental: Advagraf with Myfortic Drug: Advagraf
oral
Other Names:
  • Extended release tacrolimus
  • FK506E
  • MR4
Drug: Myfortic
oral
Other Name: Mycophenolate sodium

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018914

Locations
Taiwan
Taichung, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01018914     History of Changes
Other Study ID Numbers: ADVLTx-0901-TW
Study First Received: November 23, 2009
Last Updated: October 5, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:
Prograf
Advagraf
Myfortic

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013