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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2023

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At a glance

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

    • Most Recent Events

    • 07 Feb 2023 Results of pooled analysis from four studies (n=2142:NCT02021318, NCT02052310, NCT02273726, NCT02174731) assessing the safety of roxadustat in patients with non dialysis dependent or incident dialysis dialysis dependent chronic kidney disease published in the Advances in Therapy
    • 09 Nov 2022 Results of systematic review included some of the data from DOLOMITES, HIMALAYAS and ROCKIES for assessing efficacy and safety of hypoxia-inducible factor prolyl hydroxylase inhibitors for treatment of anaemia of chronic kidney disease, presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 19 Aug 2021 According to an Astellas Pharma, FibroGen media release, the European Commission (EC) has approved EVRENZO™ (roxadustat) for the treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD).

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