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

Novartis

Status and phase: Completed; Phase 4

Conditions: Renal Transplantation

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00170820

CRAD001AFR04

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)