34
Participants
Start Date
May 31, 2006
Primary Completion Date
April 30, 2008
Study Completion Date
January 31, 2009
Cyclosporine (Sandimmun® i.v.)
Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Cyclosporine (Sandimmun® Optoral)
Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Novartis Investigational Site, Various Cities
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY