Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

An 18 Month Extension to the Multicenter, Randomized, Open-label Trial (NCT00170885) to Evaluate the Safety, Tolerability, and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients

The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.

Inclusion Criteria:

• Patients with functioning graft who had completed the 6-month treatment period of core study
• Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study
• Patients who signed the informed consent of the present study extension

Exclusion Criteria:

- Women who were pregnant, lactating or who wished to became pregnant.

Other protocol-defined inclusion/exclusion criteria applied to the study.