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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01018914
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : January 29, 2016
Astellas Pharma Taiwan, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Study Type : Interventional  (Clinical Trial)
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 : April 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Active Comparator: Prograf with Myfortic Drug: Prograf
Other Names:
  • Tacrolimus
  • FK506

Drug: Myfortic
Other Name: Mycophenolate sodium

Experimental: Advagraf with Myfortic Drug: Advagraf
Other Names:
  • Extended release tacrolimus
  • FK506E
  • MR4

Drug: Myfortic
Other Name: Mycophenolate sodium

Primary Outcome Measures :
  1. Incidence of biopsy confirmed acute rejection [ Time Frame: during the 6 months post-transplant. ]

Secondary Outcome Measures :
  1. Patient and graft survival rates [ Time Frame: during the 6 months post-transplant ]
  2. Time to first biopsy confirmed acute rejection episode [ Time Frame: during the 6 months post-transplant ]
  3. Incidence of anti-lymphocyte antibody therapy for treatment of rejection [ Time Frame: during the 6 months post-transplant. ]
  4. Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs [ Time Frame: throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01018914

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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01018914     History of Changes
Other Study ID Numbers: ADVLTx-0901-TW
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents