383
Participants
Start Date
November 30, 2011
Primary Completion Date
December 31, 2015
Study Completion Date
December 31, 2015
Everolimus
Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.
Mycophenolate sodium
Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.
Cyclosporine
Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.
Steroids
Steroids were administered according to local clinical practice.
Novartis Investigative Site, Milan
Novartis Investigative Site, Milan
Novartis Investigative Site, Brescia
Novartis Investigative Site, Pavia
Novartis Investigative Site, Novara
Novartis Investigative Site, Padua
Novartis Investigative Site, Verona
Novartis Investigative Site, Bologna
Novartis Investigative Site, Modena
Novartis Investigative Site, Florence
Novartis Investigative Site, Siena
Novartis Investigative Site, Ancona
Novartis Investigative Site, Coppito
Novartis Investigative Site, Bari
Novartis Investigative Site, Salerno
Novartis Investigative Site, Palermo
Novartis Investigative Site, Catania
Novartis Investigative Site, Cagliari
Novartis Investigative Site, Roma
Novartis Investigative Site, Roma
Novartis Investigative Site, Roma
Novartis Investigative Site, Roma
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY