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

Phase 2CompletedNCT00820911

Novartis Pharmaceuticals175 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

Kidney Transplantation

Interventions

cyclosporine (reduced exposure) / everolimusDRUG

twice daily

AEB071 300 mg b.i.d. / everolimusDRUG

twice daily

AEB071 200 mg b.i.d. / everolimusDRUG

twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (28)

Novartis Investigative Site

Outcomes

Primary Outcomes

renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula

Time frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Secondary Outcomes

efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up

Time frame: at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Data from ClinicalTrials.gov

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