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

November 16, 2016 updated by: Novartis Pharmaceuticals

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Novartis Investigative Site
      • Buenos Aires, Argentina, 1107
        • Argentina
  • Australia
      • Sydney, Australia, 2050
        • Australia
      • Sydney, Australia, 5011
        • Australia
  • Austria
      • Innsbruck, Austria, 6020
        • Austria
      • Wein, Austria, 1090
        • Austria
  • Belgium
      • Gent, Belgium, 9000
        • Belgium
  • Brazil
      • Sao Paulo, Brazil, 04038-002
        • Brazil
  • Colombia
      • Bogota, Colombia
        • Novartis Investigative Site
      • Cali, Colombia
        • Novartis Investigative Site
  • Czech Republic
      • Praha, Czech Republic, 14021
        • Czech Republic
  • France
      • Lille Cedex, France, 59037
        • France
      • Toulouse, France, 31055
        • France
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
  • Italy
      • Milano, Italy, 20100
        • Italy
      • Milano, Italy, 20122
        • Italy
  • Netherlands
      • Rotterdam, Netherlands, 3000CA
        • Netherlands
  • Norway
      • Oslo, Norway, 0027
        • Norway
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia, 97517
        • Novartis Investigative Site
      • Kosice, Slovakia, 04066
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08024
        • Spain
      • Madrid, Spain, 28034
        • Spain
  • Switzerland
      • Zurich, Switzerland, 8091
        • Novartis Investigative Site
  • Taiwan
      • Taipie, Taiwan, 10002
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neoral
Drug: Neoral
twice daily
Active Comparator: AEB071 high dose with Cetican reduced dose
Drug: AEB071
oral, twice daily
Drug: Certican
twice daily
Active Comparator: AEB071 low dose with Cetican standard dose
Drug: AEB071
oral, twice daily
Drug: Certican
twice daily

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome 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
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEB071A2206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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