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

PHASE4CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions
Renal Transplantation
Interventions
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.

Trial Locations (3)

Unknown

Novartis Investigational Sites, Nuremberg

Novartis Pharma AG, Basel

Novartis Investigational Sites, Bern

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY