A Study of Daclizumab (Zenapax) in Combination With Mycophenolate Mofetil (CellCept) and Sirolimus in Prevention of Acute Rejection in Heart Transplant Participants

Pilot, Single-arm, Non-comparative, Open-label Study of Daclizumab in Combination With Mycophenolate Mofetil and Sirolimus in the Prevention of Acute Rejection in Cardiac Allografts Recipients in Risk of Deteriorated Renal Function

This study will evaluate the efficacy and safety of intravenous daclizumab in combination with oral mycophenolate mofetil and oral sirolimus in participants receiving a heart transplant, and at risk of impaired kidney function. The anticipated time on study treatment is 6 months, and the target sample size is 44 individuals.

Inclusion Criteria:

• Adult participants greater than 18 years of age
• Single organ (heart) transplant recipients
• At risk for post-transplant renal dysfunction

Exclusion Criteria:

• Previous organ transplant
• Previous treatment with mycophenolate mofetil, daclizumab or sirolimus
• Positive for human immunodeficiency virus (HIV) infection
• History of malignancy within the last 5 years, except localized and treated skin cancer, treated and without evident relapse