313
Participants
Start Date
December 31, 2006
Primary Completion Date
June 30, 2009
Study Completion Date
June 30, 2009
Enteric-coated mycophenolate sodium (Myfortic)
1440 mg/day for the standard dose. 2880 mg/day for the initial intensified dosage, reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
Cyclosporine (Neoral)
cyclosporine microemulsion in galenic form capsules starting at twice a day for a dose of 8-10 mg/kg/day adjusted if necessary to achieve protocol specific target levels
Prednisone
20 mg orally per day reduced according to center practice for a minimum dose of 5 mg/day.
Novartis, Basel
Lead Sponsor
Novartis
INDUSTRY