Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients

PHASE3CompletedINTERVENTIONAL
Enrollment

833

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

August 31, 2009

Study Completion Date

October 31, 2009

Conditions
Kidney TransplantationGraft Rejection
Interventions
DRUG

Everolimus

oral, bis in diem/twice a day (bid)

DRUG

Mycophenolic Acid (MPA)

2 oral capsules of mycophenolic acid 360mg administered bid

DRUG

Cyclosporine A (CsA)

CsA dose adjustments were based on CsA trough levels (C0).

DRUG

Basiliximab

All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was to be given within 2 hours prior to transplant surgery and the second dose was to be administered on day 4, or each dose could have been administered according to local practice.

DRUG

Corticosteroids

Oral corticosteroids were administered according to local practice during the trial. At the same center, all patients were to follow the same steroid administration protocol.

Trial Locations (1)

07936

Novartis, East Hanover

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY