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A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia

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Trial Profile

A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in 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) ; Darbepoetin alfa
  • 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.
    • 08 Jun 2020 According to a FibroGen media release, data from this trial was presented in virtual oral sessions of the 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress, taking place June 6 - 9, 2020
    • 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.

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