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

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

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

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.

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