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.

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.

Completed
Phase of Trial: Phase II

Latest Information Update: 21 Apr 2015

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).
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top