Status:

COMPLETED

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Kidney Transplantation

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2012

    Estimated Enrollment :

    175 Patients enrolled

    Trial Details

    Trial ID

    NCT00820911

    Start Date

    September 1 2008

    End Date

    July 1 2012

    Last Update

    February 24 2017

    Active Locations (28)

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    Page 1 of 7 (28 locations)

    1

    Novartis Investigative Site

    San Martín, Buenos Aires, Argentina, C1107BEA

    2

    Novartis Investigative Site

    Córdoba, Córdoba Province, Argentina, X5022CPU

    3

    Novartis Investigative Site

    Camperdown, New South Wales, Australia, 2050

    4

    Novartis Investigative Site

    Woodville, South Australia, Australia, 5011