NCT00251004

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

Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 833 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.

Conditions

• Kidney Transplantation
• Graft Rejection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-08-01
• Completion: 2009-10-01
• First posted: 2005-11-09
• Last updated: 2011-05-10
• Results posted: 2011-05-10

Locations

1 site across 1 country: United States