NCT00371826

SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus

A Prospective, Open-label, Controlled Multicenter Trial to Assess the Efficacy and Safety of an Induction Regimen of Cyclosporine Micro Emulsion, Enteric-coated Mycophenolate Sodium (EC-MPS) and Corticosteroids, Followed by Administration of Everolimus and Enteric-coated Mycophenolate Sodium (EC-MPS), With Either the Withdrawal of Cyclosporine Micro Emulsion or Corticosteroids in de Novo Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine micro emulsion and corticosteroids plus enteric-coated mycophenolate sodium (EC-MPS) initially, changed to everolimus at 2 weeks post-transplant. These two groups will be compared to a third control group, who will receive treatment consisting of cyclosporine micro emulsion, enteric-coated mycophenolate sodium (EC-MPS) and steroids.

Conditions

• Renal Transplanted Recipients

Interventions

Type	Name	Description
DRUG	Everolimus (RAD001)
DRUG	Cyclosporine (Calcineurin Inhibitor (CNI))
DRUG	Methylprednisone/prednisone
DRUG	Mycophenolate sodium (MPA)

Timeline

• Start date: 2006-03-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2006-09-04
• Last updated: 2013-08-19
• Results posted: 2013-08-19

Locations

7 sites across 1 country: Australia