A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation

A Double-Blind, Placebo -Controlled, Randomized Study to Assess the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation.

The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.

Inclusion Criteria:

• Participants must be undergoing their first cardiac allograft transplant
• Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to transplantation
• Women of childbearing potential must use two reliable forms of contraception simultaneously. Effective contraception must be used before beginning study drug therapy, and for 4 months following discontinuation of study drug therapy
• Participants and/or their guardians must be willing and be capable of understanding risks and comply with the purpose of the study

Exclusion Criteria:

• Previous organ transplants
• Participants receiving multiple organs
• Participants requiring ventricular assist device (VAD) upon completion of transplantation surgery
• Women lactating, pregnant or of childbearing potential not using, or who are unwilling to use two reliable forms of contraception simultaneously during the study
• History of a psychological illness or condition which would interfere with the participant's ability to understand the requirements of the study
• White blood count =<2500/mm^3, platelets =<50,000/mm^3 or hemoglobin =<6 g/dL
• HIV-1, the presence of positive HBsAg, or chronic active hepatitis C
• Active peptic ulcer disease
• Severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication
• Malignancies within the past 5 years, excluding skin carcinoma that have been adequately treated
• Participants who have received within the past 30 days or require concomitant treatment with other investigational drugs or immunosuppressive medications that are prohibited for this study
• Inability to start microemulsion form of cyclosporine within 72 hours