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A Phase 3, Multi-center, Randomized, 2-arm, Open-label Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent-naive Hemodialysis Chronic Kidney Disease Patients With Anemia

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Trial Profile

A Phase 3, Multi-center, Randomized, 2-arm, Open-label Study of Intermittent Oral Dosing of ASP1517 in Erythropoiesis Stimulating Agent-naive Hemodialysis 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)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Astellas Pharma

    • Most Recent Events

    • 05 Aug 2021 Result (n=367) of pooled analysis from four studies (NCT01888445, NCT02952092, NCT02780726 and NCT02780141) evaluating the population PK model of roxadustat in Japanese DD-CKD patients with renal anemia and to identify the covariate factors that affect roxadustat pharmacokinetic, published in the British Journal of Clinical Pharmacology.
    • 20 Sep 2019 According to a FibroGen media release, Japan's Ministry of Health, Labour and Welfare (MHLW) approved roxadustat for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients.
    • 08 Aug 2019 According to a FibroGen media release, the regulatory decision for roxadustat approval in Japan is expected in the second half of 2019.

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