434
Participants
Start Date
August 31, 1999
Primary Completion Date
August 31, 2002
Study Completion Date
August 31, 2002
Daclizumab
Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.
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).
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.
Placebo
Matching placebo will be administered on Days 1, 8, 22, 36, and 50.
cyclosporine
Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.
New York
Philadelphia
Philadelphia
Baltimore
Durham
Hanover
Tampa
Louisville
Gothenburg
Cleveland
Milwaukee
Madison
Minneapolis
Frankfurt am Main
Dallas
Dallas
Houston
Salt Lake City
Albuquerque
Los Angeles
Portland
Birmingham
Boston
Boston
Ann Arbor
Cincinnati
Pittsburgh
Charleston
London
Ottawa
Hoffmann-La Roche
INDUSTRY