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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborators: Roche Pharma AG; University of Tennessee
• Treatments: Daclizumab; Immunoglobulin G; Mycophenolate mofetil; Mycophenolic Acid; Pancreatin; Pancrelipase; Tacrolimus

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 B surface antigen positive

• Investigational drug within 30 days prior to transplant surgery

• Anti-T cell therapy within 30 days prior to transplant surgery