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

A 12 Month Open-label, Randomized, Multicenter, Sequential Cohort-group, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Cyclosporine in Combination With Everolimus, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00504543

Acronym

AEB071

Enrollment

311

Registered

2007-07-20

Start date

2007-07-31

Completion date

2011-04-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney transplant, AEB071

Brief summary

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

Interventions

DRUGAEB071

oral, twice daily

DRUGCertican

twice daily

DRUGNeoral

twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
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.	12 months

Secondary

Measure	Time frame
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	12 months

Countries

Argentina, Australia, Austria, Belgium, Brazil, Colombia, Czechia, France, Germany, Italy, Netherlands, Norway, Singapore, Slovakia, Spain, Switzerland, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026