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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.

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Trial Profile

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
Phase of Trial: Phase II

Latest Information Update: 21 Apr 2015

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At a glance

  • Drugs Sotrastaurin (Primary) ; Basiliximab; Ciclosporin; Corticosteroids; Everolimus
  • Indications Renal transplant rejection
  • Focus Therapeutic Use

Most Recent Events

  • 01 May 2012 Primary endpoint 'Clinical-failure-rate' has not been met.
  • 15 Nov 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov (NCT00504543).
  • 01 Nov 2011 Planned End Date changed from 1 Mar 2011 to 1 Apr 2011 as reported by ClinicalTrials.gov. (parent trial: NCT00504543).

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