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

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Transplantation Immunology; Host vs Graft Reaction
• Intervention / Treatment: Drug: Prograf-XL; Drug: MMF; Drug: Prograf

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
  • Taipei, Taiwan, 100
  • Taipei, Taiwan, 112
  • Taoyuan, Taiwan, 333

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prograf-XL + MMF	Drug: Prograf-XL; oral; Other Names: FK506E; tacrolimus extended release; MR4; Drug: MMF; oral; Other Names: Mycophenolate Mofetil
Active Comparator: Prograf + MMF	Drug: MMF; oral; Other Names: Mycophenolate Mofetil; Drug: Prograf; oral; Other Names: FK506; tacrolimus

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient and graft survival rates during the 6 and 12 months post-transplant	6 and 12 month
Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 12 months post-transplant	12 month
Incidence of anti-lymphocyte antibody therapy for treatment of rejection during the 6 and 12 months post-transplant	6 and 12 month

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Taiwan, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: July 18, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Combination drug therapy; Immunosuppressant; Graft loss; Open level method
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Tacrolimus; Mycophenolic Acid
• Other Study ID Numbers: PRGXLLTx-0702-TW