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A Phase 3, Multicenter, Randomized, 2-Arm, Open-label Study of Intermittent Oral Dosing of ASP1517 for the Treatment of Anemia in Erythropoiesis Stimulating Agent-untreated Chronic Kidney Disease Patients Not on Dialysis

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Trial Profile

A Phase 3, Multicenter, Randomized, 2-Arm, Open-label Study of Intermittent Oral Dosing of ASP1517 for the Treatment of Anemia in Erythropoiesis Stimulating Agent-untreated Chronic Kidney Disease Patients Not on Dialysis

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

  • 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.
  • 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.
  • 29 Jan 2020 According to an Astellas Pharma media release, the company has submitted a supplemental New Drug Application (sNDA) to Japan's Ministry of Health, Labour and Welfare to gain marketing approval for Evrenzo (generic name: roxadustat) for the treatment of anemia associated with chronic kidney disease (CKD) in non-dialysis dependent (NDD) patients, based on the data from this and other two trials (NCT01964196 and NCT02988973).

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