115
Participants
Start Date
November 30, 2009
Primary Completion Date
December 31, 2012
Study Completion Date
December 31, 2012
Cyclosporine
Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3)
Mycophenolate mofetil
Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11
Corticosteroids
Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.
Everolimus
Everolimus 0.75 mg twice a day as starting dose up to a target blood level: 3-6 ng/mL (7-11 weeks) and 6-10 ng/mL for remaining of study
Anti Thymocyte Globulin
Induction therapy, Anti Thymocyte Globulin (ATG): 1-2 mg/kg/day during 3-5 days for control and everolimus groups after transplant surgery and prior to randomization.
Novartis Investigative Site, Århus N
Novartis Investigative Site, Copenhagen
Novartis Investigative Site, Oslo
Novartis Investigative Site, Gothenburg
Novartis Investigative Site, Linköping
Novartis Investigative Site, Lund
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY