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

February 22, 2017 updated by: Novartis Pharmaceuticals

An Extension to a 12-month, Open-label, Randomised, Multicenter, Sequential Cohort, 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)

175

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
      • Cordoba, Argentina, X5022CPU
        • Novartis Investigative Site
    • Buenos Aires
      • San Martin, Buenos Aires, Argentina, C1107BEA
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Novartis Investigative Site
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
  • Austria
      • Innsbruck, Austria, A-6020
        • Novartis Investigative Site
  • Belgium
      • Gent, Belgium, 9000
        • Novartis Investigative Site
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • Novartis Investigative Site
    • SP
      • São Paulo, SP, Brazil, 04023-900
        • Novartis Investigative Site
  • Colombia
      • Bogotá, Colombia
        • Novartis Investigative Site
      • Cali, Colombia
        • Novartis Investigative Site
  • Czech Republic
      • Praha 4, Czech Republic, 140 00
        • Novartis Investigative Site
  • France
      • Brest, France, 29200
        • Novartis Investigative Site
      • Nantes Cedex, France, 44035
        • Novartis Investigative Site
      • Toulouse Cedex 4, France, 31054
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
  • Italy
    • MI
      • Milano, MI, Italy, 20162
        • Novartis Investigative Site
      • Milano, MI, Italy, 20122
        • Novartis Investigative Site
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway, 0424
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Novartis Investigative Site
    • Slovak Republic
      • Kosice, Slovak Republic, Slovakia, 041 90
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28034
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Novartis Investigative Site
  • Switzerland
      • Zurich, Switzerland, 8091
        • Novartis Investigative Site
  • Taiwan
      • Taipei, 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: cyclosporine (reduced exposure) / everolimus
Drug: cyclosporine (reduced exposure) / everolimus
twice daily
Experimental: AEB071 300 mg b.i.d. / everolimus
Drug: AEB071 300 mg b.i.d. / everolimus
twice daily
Experimental: AEB071 200 mg b.i.d. / everolimus
Drug: AEB071 200 mg b.i.d. / everolimus
twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

September 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEB071A2206E1
  • 2008-000531-18 (EudraCT Number)

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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