Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess safety and efficacy of AEB071 combined with everolimus in a CNI-free (calcineurin inhibitor) regimen in renal transplant recipients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Cyclosporine; Cyclosporins; Everolimus

Criteria

Inclusion criteria

• Male and female patients 18 years or older

• Recipients of first kidney transplant from a deceased or living not related donor

Exclusion criteria

• Need for medication prohibited in the study

• Patients with heart disease (own or family history)

• Patients or donor HIV, Hepatitis B (HBsAg) or Hepatitis C (HCV) positive

• Patients with high immunological risks

• Patients with a history of cancer

• Other protocol-defined inclusion/exclusion criteria may apply