NCT00154310

Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients

Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a CNI-free Regimen With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Everolimus in Comparison to Standard Therapy With Enteric-Coated Mycophenolate Sodium (EC-MPS) and Cyclosporine Microemulsion in de Novo Renal Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL.
DRUG	Cyclosporine	Tablets orally twice a day to maintain protocol specific target blood levels
DRUG	Enteric-coated mycophenolate sodium	Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day.
DRUG	Corticosteroids	Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.

Timeline

• Start date: 2005-06-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2005-09-12
• Last updated: 2013-11-13
• Results posted: 2011-05-24

Locations

3 sites across 2 countries: Germany, Switzerland