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An international, double-blind, placebo-controlled, parallel group Pivotal trial of Bardoxolone in the patients with Autosomal-dominant-polycystic-kidney-disease

Trial Profile

An international, double-blind, placebo-controlled, parallel group Pivotal trial of Bardoxolone in the patients with Autosomal-dominant-polycystic-kidney-disease

Planning
Phase of Trial: Phase III

Latest Information Update: 03 Jan 2019

At a glance

  • Drugs Bardoxolone methyl (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Registrational; Therapeutic Use
  • Acronyms FALCON
  • Sponsors Reata Pharmaceuticals
  • Most Recent Events

    • 03 Jan 2019 According to a Reata Pharmaceuticals media release,Based upon guidance from the FDA, the 52-week retained eGFR benefit data of this trial may support accelerated approval under subpart H. Based upon guidance from the FDA, the year-two retained eGFR benefit data may support full approval.
    • 03 Jan 2019 According to a Reata Pharmaceuticals media release, has completed an end-of-Phase 2 meeting with the US FDA regarding the design of this trial. Company expects to initiate enrollment in the trial during mid-2019.
    • 22 Nov 2018 New trial record
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