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A Japanese, Phase 2, Multicenter, Randomized, 4-arm Parallel, Double-blind (Arms 1-3), Open-label (Arm 4), Active-comparator (Darbepoetin Alfa) Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis-dependent Chronic Kidney Disease Patients With Anemia

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Trial Profile

A Japanese, Phase 2, Multicenter, Randomized, 4-arm Parallel, Double-blind (Arms 1-3), Open-label (Arm 4), Active-comparator (Darbepoetin Alfa) Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis-dependent Chronic Kidney Disease Patients With Anemia

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 17 Aug 2021

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At a glance

  • Drugs Roxadustat (Primary) ; Darbepoetin alfa
  • Indications Anaemia
  • Focus 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.
  • 25 Jul 2016 Primary endpoint (Haemoglobin level) has been met, as reported in an Astellas Pharma media release.
  • 25 Jul 2016 Results published in an Astellas Pharma media release.

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