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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

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: 06 Feb 2026

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At a glance

  • Drugs Roxadustat (Primary)
  • Indications Anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Astellas Pharma

Most Recent Events

  • 07 Jan 2026 According to FibroGen media release, FibroGen is now called as Kyntra Bio.
  • 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.

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