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

Roche

Status and phase: Completed; Phase 4

Conditions: Heart Transplantation

Treatments: Drug: Placebo; Drug: Mycophenolate mofetil; Drug: cyclosporine; Drug: Methylprednisolone; Drug: Daclizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048165

NR15880

Details and patient eligibility

About

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.

Enrollment: 434 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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434 participants in 2 patient groups, including a placebo group

Daclizumab

Experimental group

Description:

Daclizumab will be administered as a intravenous dose of 1 milligrams per kilogram \[mg/kg\] on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily \[BID\], cyclosporine 1-4 mg/kg IV or 2-6 mg/kg, and 500-1000 mg IV methylprednisolone peri operative switch to oral at 0.5-1 mg/kg/day followed by tapering.

Treatment:

Drug: Daclizumab

Drug: cyclosporine

Drug: Mycophenolate mofetil

Drug: Methylprednisolone

Placebo

Placebo Comparator group

Description:

Matching placebo will be administered on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily \[BID\], cyclosporine 1-4 mg/kg IV or 2-6 mg/kg orally, and 500-1000 mg IV methylprednisolone peri-op switch to oral at 0.5-1 mg/kg/day followed by tapering.

Treatment:

Drug: cyclosporine

Drug: Mycophenolate mofetil

Drug: Placebo

Drug: Methylprednisolone