Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids

PHASE4CompletedINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Inflammation
Interventions
DRUG

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

DRUG

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."

Trial Locations (4)

Unknown

Labbafinejad Hospital, Tehran

Modarres Hospital, Tehran

Shariati Hospital, Tehran

Taleqani Hospital, Tehran

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY