323
Participants
Start Date
February 29, 2008
Primary Completion Date
February 28, 2011
Study Completion Date
February 28, 2011
Alefacept
Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
tacrolimus
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
basiliximab
Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
mycophenolate mofetil
Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
Corticosteroids
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
Mt. Sinai School of Medicine, New York
New York Presbyterian Hospital - Cornell, New York
Westchester Medical Center, Valhalla
Buffalo General Hospital, Buffalo
Pinnacle Health at Harrisburg, Harrisburg
University of Pennsylvania, Philadelphia
University of Maryland Center, Baltimore
Virginia Commonwealth University School of Medicine, Richmond
University of North Carolina, Chapel Hill
Duke University Medical Center, Durham
Medical College of Georgia, Augusta, Augusta
Mayo Clinic - Jacksonville, Jacksonville
University of Florida, Shands Hospital, Gainesville, Gainesville
Methodist University Hospital - Memphis, Memphis
University of Kentucky, Lexington
University Hospital of Cleveland, Cleveland
University of Michigan, Ann Arbor
University of Wisconsin Hospital, Madison
Rush - Presbyterian - St. Lukes Medical Center, Chicago
University of Illinois at Chicago, Chicago
University of Chicago Medical Center, Chicago
Baylor University Medical Center, Dallas
Methodist Hospital Research Institute of Houston, Houston
University of Colorado Health Science Center, Aurora
University of Utah Medical Center, Salt Lake City
University of Southern California - University Hospital, Los Angeles
St. Vincent/National Institute of Transplantation, Los Angeles
UCSD, San Diego
California Institute of Renal Research/Sharp Memorial Hospital, San Diego
Loma Linda University Medical Center, Loma Linda
University of California - San Francisco, San Francisco
UC Davis Medical Center, Sacramento
Legacy Transplant Services, Portland
Oregon Health & Science University, Portland
University of Washington Medical Center, Seattle
Tufts Medical Center, Boston
Brigham and Women's Hospital, Boston
St. Barnabas Medical Center, Livingston
Lead Sponsor
Astellas Pharma Inc
INDUSTRY