300
Participants
Start Date
June 30, 2005
Primary Completion Date
September 30, 2008
Study Completion Date
September 30, 2008
Everolimus
Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL.
Cyclosporine
Tablets orally twice a day to maintain protocol specific target blood levels
Enteric-coated mycophenolate sodium
Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day.
Corticosteroids
Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
Novartis Investigational Sites, Nuremberg
Novartis Pharma AG, Basel
Novartis Investigational Sites, Bern
Lead Sponsor
Novartis
INDUSTRY