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A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.

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ClinicalTrials.gov Identifier: NCT00720408
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : September 15, 2009
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by:
Astellas Pharma Inc

Brief Summary:
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients

Condition or disease Intervention/treatment Phase
Liver Transplantation Transplantation Immunology Host vs Graft Reaction Drug: Prograf-XL Drug: Prograf Drug: MMF Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 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)/MMF and Extended Release (XL) Tacrolimus /MMF and Steroid Withdraw in de Novo Liver Transplant Recipients.
Study Start Date : December 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prograf-XL + MMF Drug: Prograf-XL
oral
Other Names:
  • tacrolimus extended release
  • FK506E
  • MR4
Drug: MMF
oral
Other Name: Mycophenolate Mofetil
Active Comparator: Prograf + MMF Drug: Prograf
oral
Other Names:
  • tacrolimus
  • FK506
Drug: MMF
oral
Other Name: Mycophenolate Mofetil



Primary Outcome Measures :
  1. Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant. [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Patient and graft survival rates during the 6 and 12 months post-transplant [ Time Frame: 6 and 12 month ]
  2. Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 12 months post-transplant [ Time Frame: 12 month ]
  3. Incidence of anti-lymphocyte antibody therapy for treatment of rejection during the 6 and 12 months post-transplant [ Time Frame: 6 and 12 month ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
  • Patient is a primary liver transplant recipient
  • Patient must receive first dose of XL or Prograf (or IV tacrolimus for subjects unable to tolerate oral study drug) within 48 hours of transplantation
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant

Exclusion Criteria:

  • Patient has previously received or is receiving an organ transplant other than a liver
  • Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
  • Patient has received a liver transplant from a non-heart beating donor
  • Patient has received an ABO incompatible donor liver
  • Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria 21 and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully
  • 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 has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
  • 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, mycophenolate mofetil or corticosteroids
  • Patient is pregnant or lactating
  • Patient is unlikely to comply with the visits scheduled in the protocol, including the protocol biopsies
  • Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator

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 ClinicalTrials.gov identifier (NCT number): NCT00720408


Locations
Taiwan
Kaohsiung, Taiwan, 833
Taipei, Taiwan, 100
Taipei, Taiwan, 112
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Investigators
Study Chair: Central Contact Astellas Pharma Inc

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00720408     History of Changes
Other Study ID Numbers: PRGXLLTx-0702-TW
First Posted: July 22, 2008    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Keywords provided by Astellas Pharma Inc:
Immunosuppressant
Graft loss
Combination drug therapy
Randomized controlled trial
Open level method

Additional relevant MeSH terms:
Tacrolimus
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