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

Novartis

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: AEB071; Drug: Neoral; Drug: Certican

Study type: Interventional

Funder types: Industry

Identifiers

NCT00504543

CAEB071A2206

Details and patient eligibility

About

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

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

311 participants in 3 patient groups

Neoral

Active Comparator group

Treatment:

Drug: Neoral

AEB071 high dose with Cetican reduced dose

Active Comparator group

Treatment:

Drug: Certican

Drug: AEB071

AEB071 low dose with Cetican standard dose

Active Comparator group

Treatment:

Drug: Certican

Drug: AEB071