A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
Condition: Heart Transplantation
Intervention: Daclizumab; Methylprednisolone; Mycophenolate mofetil; Placebo; cyclosporine
Intervention description: Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.; Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days).; Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days.; Matching placebo will be administered on Days 1, 8, 22, 36, and 50.; Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Methylprednisolone; Cyclosporins; Daclizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 434.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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