A Trial of Two Daclizumab Dosing Strategies Vs. No Induction Treatment With Tacrolimus, MMF, & Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.
Sponsors:
University of Cincinnati Hoffmann-La Roche University of Tennessee
Provider:
University of Cincinnati
Locations:
University of California - Davis, Davis, California, United States University of California - Los Angeles, Los Angeles, California, United States Washington Hospital, Washington, District of Columbia, United States University of Miami, Miami, Florida, United States Emory University, Atlanta, Georgia, United States University of Chicago, Chicago, Illinois, United States Northwestern University, 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 Duke University, Durham, North Carolina, United States Carolina Medical Center, Charlotte, 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
Conditions:
Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Eligibility:
Genders Eligible for Study: Both
Minimum Age Requirement: 18 Years
Maximum Age Requirement: 65 Years
Inclusion Criteria:
• Simultaneous kidney/pancreas transplant recipients • 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:
• Prior treatment with daclizumab • 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 BsAg positive • Investigational drug within 30 days prior to transplant surgery • Anti-T cell therapy within 30 days prior to transplant surgery
Description:
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary maintenance immunosuppression.
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