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A Phase II/III trial of XRx-008 in autosomal dominant polycystic kidney disease patients

Trial Profile

A Phase II/III trial of XRx-008 in autosomal dominant polycystic kidney disease patients

Planning
Phase of Trial: Phase II/III

Latest Information Update: 26 Nov 2018

At a glance

  • Drugs Oxipurinol (Primary)
  • Indications Autosomal dominant polycystic kidney disease
  • Focus Registrational; Therapeutic Use
  • Sponsors XORTX Therapeutics
  • Most Recent Events

    • 26 Nov 2018 According to a XORTX Therapeutics media release, Over the next year the company will submit pivotal phase 2/3 protocol, discuss special protocol approval (SPA) with FDA, initiate clinical trial in 2019 and will continue to communicate with the FDA regarding a SPA for that trial
    • 30 Oct 2018 New trial record
    • 23 Oct 2018 According to a XORTX Therapeutics media release, the company had a pre-IND meeting with the FDA. As per guidance from the FDA the company will conduct this trial under a Special Protocol Assessment.
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