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

PHASE4CompletedINTERVENTIONAL
Enrollment

434

Participants

Timeline

Start Date

August 31, 1999

Primary Completion Date

August 31, 2002

Study Completion Date

August 31, 2002

Conditions
Heart Transplantation
Interventions
DRUG

Daclizumab

Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.

DRUG

Methylprednisolone

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).

DRUG

Mycophenolate mofetil

Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days.

DRUG

Placebo

Matching placebo will be administered on Days 1, 8, 22, 36, and 50.

DRUG

cyclosporine

Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.

Trial Locations (30)

10032

New York

19104

Philadelphia

19140

Philadelphia

21287

Baltimore

27710

Durham

30625

Hanover

33606

Tampa

40202

Louisville

41345

Gothenburg

44195

Cleveland

53215

Milwaukee

53792

Madison

55455

Minneapolis

60590

Frankfurt am Main

75230

Dallas

75246

Dallas

77030

Houston

84132

Salt Lake City

87106

Albuquerque

90095

Los Angeles

97201

Portland

35294-0006

Birmingham

02111

Boston

02115

Boston

48109-0366

Ann Arbor

45267-0542

Cincinnati

15213-2582

Pittsburgh

29425-2221

Charleston

N6A 5A5

London

K1Y 4W7

Ottawa

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT00048165 - A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation | Biotech Hunter | Biotech Hunter