Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

Novartis

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: cyclosporine (reduced exposure) / everolimus; Drug: AEB071 300 mg b.i.d. / everolimus; Drug: AEB071 200 mg b.i.d. / everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00820911

2008-000531-18 (EudraCT Number)

CAEB071A2206E1

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: 175 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has been maintained on study drug for 12 months in the core study

Exclusion criteria

• Not applicable
• Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 3 patient groups

cyclosporine (reduced exposure) / everolimus

Active Comparator group

Treatment:

Drug: cyclosporine (reduced exposure) / everolimus

AEB071 300 mg b.i.d. / everolimus

Experimental group

Treatment:

Drug: AEB071 300 mg b.i.d. / everolimus

AEB071 200 mg b.i.d. / everolimus

Experimental group

Treatment:

Drug: AEB071 200 mg b.i.d. / everolimus