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

Novartis Pharmaceuticals311 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

311

Conditions

Kidney Transplantation

Interventions

AEB071DRUG

oral, twice daily

CerticanDRUG

twice daily

NeoralDRUG

twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (26)

Argentina

Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Outcomes

Primary Outcomes

Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection,(BPAR) graft loss, death or loss to follow-up, 3 months after transplantation.

Time frame: 12 months

Secondary Outcomes

Primary efficacy failure endpoint,defined as a composite efficacy endpoint of treated(BPAR),graft loss, death or loss to follow-up of additional treatment regimen at Month 6; renal function at Month 3, Month 6 and Month 12 post transplant using GFR; PK

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.