A Trial of Two Daclizumab Dosing Strategies vs. No Induction Treatment With Tacrolimus, Mycophenolate Mofetil , & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
NCT ID: NCT00363116
Last Updated: 2013-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
298 participants
INTERVENTIONAL
1999-04-30
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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5 Dose Daclizbumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
2 Dose Daclizaumab
daclizumab 2 mg/kg/dose every 14 days for 2 doses
Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Control
no antibody induction
Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Interventions
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Daclizumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
Eligibility Criteria
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Inclusion Criteria
* Insulin dependent Type 1 or 2 diabetes pretransplant
* Recipient age 18-65 years
* Donor age 5-65 years
* Women must have negative serum pregnancy test and practice birth control for study duration
* Negative T-cell crossmatch
* Parent (or guardian) is able to understand the consent form and give written informed consent
Exclusion Criteria
* Known sensitivity or contraindication to tacrolimus, MMF, or steroids
* Patient with significant or active infection
* Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
* Patients whose life expectancy is severely limited by diseases other than renal disease
* Ongoing substance abuse, drug or alcohol
* Major ongoing psychiatric illness or recent history of noncompliance
* Insufficient cardiovascular reserve
* Malignancy within last 5 years, excluding nonmelanoma skin cancers
* Serologic evidence of infection with HIV or Hepatitis B surface antigen positive
* Investigational drug within 30 days prior to transplant surgery
* Anti-T cell therapy within 30 days prior to transplant surgery
18 Years
65 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
University of Tennessee
OTHER
University of Cincinnati
OTHER
Responsible Party
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Rita Alloway
Investigator
Principal Investigators
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Robert J Stratta, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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University of California - Davis
Davis, California, United States
University of California - Los Angeles
Los Angeles, California, United States
Washington Hospital
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland
College Park, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cornell University
Ithaca, New York, United States
Carolina Medical Center
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Oregon Health Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee
Memphis, Tennessee, United States
University of Texas - Houston
Houston, Texas, United States
Baylor University
Waco, Texas, United States
Medical College of Virginia
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Toronto Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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ZEN049
Identifier Type: -
Identifier Source: org_study_id