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

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