95
Participants
Start Date
January 18, 2016
Primary Completion Date
September 25, 2017
Study Completion Date
September 25, 2017
Everolimus
"All patients, independent of their initial randomization in the core study, were followed up as in one single group~Commercially available everolimus (Certican®), oral route, was used."
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.
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