260
Participants
Start Date
January 31, 2008
Primary Completion Date
March 31, 2010
Study Completion Date
June 30, 2011
Tacrolimus
Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\])
Basiliximab
Intravenous (IV), 20 mg, Day1 and Day 5
Belatacept More Intensive (MI)
"Intravenous (IV),~10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24.~After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\])"
Belatacept Less Intensive (LI)
"Intravenous (IV),~10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12.~After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE)"
Mycophenolate Mofetil (MMF)
Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])
Local Institution, Vienna
Nyu School Of Medicine, New York
Westchester Medical Center, Valhalla
Local Institution, Berlin
Hospital Of The University Of Pennsylvania, Philadelphia
Local Institution, Hamburg
Local Institution, Rio de Janeiro
Local Institution, Bergamo
Carolinas Medical Center, Charlotte
Emory University Hospital, Atlanta
Local Institution, Hanover
Local Institution, Toulouse
Mayo Clinic Transplant Department, Jacksonville
Lifelink Healthcare Institute, Tampa
Local Institution, Montpellier
Local Institution, Padua
Univ. Of Cin. Coll. Of Med., Cincinnati
Henry Ford Hospital, Detriot
Froedtert Memorial Lutheran Hospital, Milwaukee
University Of Minnesota, Minneapolis
Local Institution, Pisa
Northwestern University Feinberg School Of Medicine, Chicago
Washington University School Of Medicine, St Louis
Local Institution, Heidelberg
Local Institution, Lyon
Tulane Center For Abdominal Transplant, New Orleans
Local Institution, Tübingen
Integris-Baptist Medical Ctr., Oklahoma City
Local Institution, Paris
Baylor University Medical Center, Dallas
Local Institution, Curitiba
Mayo Clinic Hospital, Phoenix
Local Institution, Centro-Porto Alegre
Usc University Hospital, Los Angeles
Local Institution, Clichy
University Of California San Francisco Medical Center, San Francisco
Local Institution, Villejuif
Local Institution, Ciudad de Buenos Aires
Local Institution, Edmonton
Local Institution, Toronto
Local Institution, Roma
Local Institution, Barcelona
Lead Sponsor
Bristol-Myers Squibb
INDUSTRY