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

Purpose

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	Intervention	Phase
Liver Transplantation Transplantation Immunology Host vs Graft Reaction	Drug: Prograf-XL Drug: Prograf Drug: MMF	Phase 3

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)/MMF and Extended Release (XL) Tacrolimus /MMF and Steroid Withdraw in de Novo Liver Transplant Recipients.

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Mycophenolic acid Mycophenolate sodium Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate mofetil

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	48
Study Start Date:	December 2007
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

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

More Information

No publications provided

Responsible Party:	Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier:	NCT00720408 History of Changes
Other Study ID Numbers:	PRGXLLTx-0702-TW
Study First Received:	July 18, 2008
Last Updated:	September 14, 2009
Health Authority:	Taiwan: Department of Health

Keywords provided by Astellas Pharma Inc:

Immunosuppressant
Graft loss
Combination drug therapy
Randomized controlled trial
Open level method

Additional relevant MeSH terms:

Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013