Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients

A Controlled Randomized Open-label Multicenter Study Evaluating if Early Conversion to Everolimus (Certican) From Cyclosporine (Neoral) in de Novo Renal Transplant Recipients Can Improve Long-term Renal Function and Slow Down the Progression of Chronic Allograft Nephropathy

This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy

Inclusion Criteria:

• First or second single renal transplant from deceased or living donor

Exclusion criteria

• Recipient of organs other than a renal transplant
• Present malignancy (within the last 2 years) other than excised basal cell or squamous cell carcinoma of the skin
• Severe liver disease
• At the time of randomization 7 weeks after transplantation

In addition to the above criteria the following must be met at time of randomization:

Inclusion Criteria:

• Patients maintained on a triple immunosuppressive regime consisting of cyclosporine, Enteric coated mycophenolate, and corticosteroids
• Patients completed the first 7 weeks without experiencing any rejection

Exclusion Criteria:

• Graft loss
• Low hemoglobin value, low number of white blood cells or platelets
• High cholesterol values
• Proteinuria
• Wound healing problems
• Current severe major local or systemic infection
• Renal insufficiency

Other protocol-defined inclusion/exclusion criteria may apply.