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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Taiwan, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00720408
First received: July 18, 2008
Last updated: September 14, 2009
Last verified: September 2009

July 18, 2008
September 14, 2009
December 2007
September 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00720408 on ClinicalTrials.gov Archive Site
  • Patient and graft survival rates during the 6 and 12 months post-transplant [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of anti-lymphocyte antibody therapy for treatment of rejection during the 6 and 12 months post-transplant [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Liver Transplantation
  • Transplantation Immunology
  • Host vs Graft Reaction
  • Drug: Prograf-XL
    oral
    Other Names:
    • tacrolimus extended release
    • FK506E
    • MR4
  • Drug: Prograf
    oral
    Other Names:
    • tacrolimus
    • FK506
  • Drug: MMF
    oral
    Other Name: Mycophenolate Mofetil
  • Experimental: Prograf-XL + MMF
    Interventions:
    • Drug: Prograf-XL
    • Drug: MMF
  • Active Comparator: Prograf + MMF
    Interventions:
    • Drug: Prograf
    • Drug: MMF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00720408
PRGXLLTx-0702-TW
No
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Astellas Pharma Taiwan, Inc.
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
September 2009

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