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A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney Disease Patients With Anemia

Trial Profile

A Phase 3 Multi-center, Randomized, Open-label, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Non-dialysis Chronic Kidney Disease Patients With Anemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

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

    • 26 Nov 2020 According to an Astellas Pharma media release, Japan's Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis, based on the data from NCT02988973, NCT02964936 and NCT01964196.
    • 19 Oct 2020 According to a FibroGen media release, data form this study will be presented at the American Society of Nephrology (ASN) Kidney Week 2020.
    • 06 Aug 2020 According to a FibroGen media release, Japan sNDA for roxadustat for the treatment of anemia of CKD in non-dialysis-dependent patients is under review.
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