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A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan

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A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 11 Dec 2021

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At a glance

  • Drugs Molidustat (Primary) ; Epoetin alfa; Epoetin alfa; Epoetin beta; Epoetin beta
  • Indications Anaemia
  • Focus Therapeutic Use
  • Acronyms DIALOGUE4
  • Sponsors Bayer

    • Most Recent Events

    • 10 Jan 2020 Results (N=42), assessing drug-drug interaction of Molidustat with iron and calcium supplements in patients with anemia as a result of chronic kidney disease, published in the European Journal of Clinical Pharmacology
    • 11 Jan 2016 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 15 Oct 2015 Planned primary completion date changed from 1 Jan 2016 to 1 Oct 2015 as reported by ClinicalTrials.gov.

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