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
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Intervention: Daclizumab (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Robert J Stratta, MD, Principal Investigator, Affiliation: University of Tennessee
Summary
The purpose of the study is to determine the safety and efficacy of two dosing regimens of
daclizumab in simultaneous kidney/pancreas transplant recipients.
Clinical Details
Official title: An Open-Label, Comparative Trial of Two Daclizumab Dosing Strategies Versus No Induction Treatment in Combination With Tacrolimus, Mycophenolate Mofetil, and Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
Study design: Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant.
Secondary outcome: Incidence, timing and severity of fungal infections.Incidence, timing and severity of malignancies. Hospitalizations.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of California - Davis, Davis, California 95616, United States
University of California - Los Angeles, Los Angeles, California 90095, United States
Washington Hospital, Washington, District of Columbia 20010, United States
University of Miami, Miami, Florida 33124, United States
Emory University, Atlanta, Georgia 30322, United States
University of Chicago, Chicago, Illinois 60637, United States
Northwestern University, Chicago, Illinois 60208, United States
University of Iowa, Iowa City, Iowa 52242, United States
University of Maryland, College Park, Maryland 20742, United States
University of Minnesota, Minneapolis, Minnesota 55455, United States
Cornell University, Ithaca, New York 14853, United States
Duke University, Durham, North Carolina 27708, United States
Carolina Medical Center, Charlotte, North Carolina 28203, United States
Ohio State University, Columbus, Ohio 43210, United States
Toronto Hospital, Toronto, Ontario M5G 2C4, Canada
Oregon Health Science University, Portland, Oregon 97239, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
University of Tennessee, Memphis, Tennessee 38163, United States
University of Texas - Houston, Houston, Texas 77030, United States
Baylor University, Waco, Texas 76798, United States
Medical College of Virginia, Richmond, Virginia 23298, United States
University of Washington, Seattle, Washington 98195, United States
University of Wisconsin, Madison, Wisconsin 53705, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Additional Information
Last updated: August 10, 2006
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