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

Completed · Phase 4

Conditions studied: Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients

In brief

The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.

Key facts

Study ID

NCT00363116

Run by

University of Cincinnati

People needed

298

Starts

1999-04-01

Expected to finish

2004-12-01

Last updated by the study team

2013-10-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 B surface antigen positive
• Investigational drug within 30 days prior to transplant surgery
• Anti-T cell therapy within 30 days prior to transplant surgery

Where it is running

• 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

Full record on ClinicalTrials.gov

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