A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Trial Profile

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2017

At a glance

  • Drugs Roxadustat (Primary) ; Darbepoetin alfa
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms Dolomites
  • Sponsors Astellas Pharma Europe Ltd
  • Most Recent Events

    • 26 Jul 2017 Planned End Date changed from 1 Jul 2017 to 1 Apr 2020.
    • 26 Jul 2017 Planned primary completion date changed from 1 Jul 2017 to 1 Dec 2018.
    • 29 Jun 2015 Approximately 8000 chronic kidney disease patients will be enrolled in this and nine other phase III trials, according to a FibroGen media release.
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