Efficacy and Safety of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

A Single Arm, Prospective, Open-label, Pilot Study to Assess Effects of the Switch From Sirolimus to Everolimus in Stable Maintenance Renal Transplant Patients Receiving a Calcineurin Inhibitor Free Regimen

The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.

Inclusion Criteria:

• First or second renal transplantation (1 to 10 years post-transplant)
• Treatment with sirolimus + mycophenolate mofetil + steroids + ACE inhibitor or angiotensin II receptor antagonist + statin

Exclusion Criteria

• Treatment with a CNI or azathioprine
• Vascular rejection or biopsy-proven acute rejection within 3 months prior to screening
• Severe dyslipidemia Other protocol-defined inclusion / exclusion criteria may apply