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

NCT00720408 | Completed Phase 3

• 1 other identifier: PRGXLLTx-0702-TW
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

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

Conditions

Liver Transplantation; Transplantation Immunology; Host vs Graft Reaction

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  6 month

Secondary Outcomes (3)

• 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

Study Arms (2)

Prograf-XL + MMF

EXPERIMENTAL

Drug: Prograf-XL; Drug: MMF

Prograf + MMF

ACTIVE COMPARATOR

Drug: Prograf; Drug: MMF

Interventions

Prograf-XL DRUG

oral

Also known as: tacrolimus extended release, FK506E, MR4

Prograf-XL + MMF

Prograf DRUG

oral

Also known as: tacrolimus, FK506

Prograf + MMF

MMF DRUG

oral

Also known as: Mycophenolate Mofetil

Prograf + MMF; Prograf-XL + MMF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Taiwan, Inc.: collaborator

Study Sites (4)

Unknown Facility

Kaohsiung City, 833, Taiwan

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Unknown Facility

Taipei, 112, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Interventions

Tacrolimus; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Study Officials

• Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 15, 2009

Record last verified: 2009-09

Locations

TW (4)