245
Participants
Start Date
April 30, 2006
Primary Completion Date
March 31, 2008
Study Completion Date
March 31, 2008
CsA+Rapamune+CS
Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months
CsA+MMF+CS
"The control arm is the standard local practice (official protocol) in Iran:~Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS."
Labbafinejad Hospital, Tehran
Modarres Hospital, Tehran
Shariati Hospital, Tehran
Taleqani Hospital, Tehran
Lead Sponsor
Pfizer
INDUSTRY