Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids

PHASE3CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

August 31, 2010

Study Completion Date

May 31, 2012

Conditions
Kidney Transplantation
Interventions
DRUG

Everolimus

0.75 mg twice daily, trough level adjusting between 3 and 8 ng/ml.

DRUG

Mycophenolate mofetil (MMF)

The initial dose of 2 gm/day Mycophenolate mofetil was started within 24-36 hours from reperfusion after transplantation. MMF was administered daily for 12 months in the core study and 12 months in the extension study.

DRUG

Basiliximab

Patients received first dose of basiliximab (20 mg) 2 hours prior to transplantation and 20 mg at Day 4 or according to local practice

DRUG

Cyclosporine A

The cyclosporine was initiated either pre-transplant or within 24 hours after transplantation following local regime. Standard dose of cyclosporine was administered with MMF. The Reduced dose of cyclosporine was administered with everolimus.

DRUG

Corticosteroid

Corticosteroid was administered according to local practice during the trial but at a dose not less than 5mg per day for 12 months of the study

Trial Locations (1)

106-8618

Novartis Pharma K.K., Japan, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY

NCT00658320 - Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids | Biotech Hunter | Biotech Hunter