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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Calcineurin Inhibitors; Everolimus; Sirolimus

Criteria

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