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Pediatric study of ferumoxytol (feraheme) for treatment of iron deficiency anaemia in patients with chronic kidney disease

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Trial Profile

Pediatric study of ferumoxytol (feraheme) for treatment of iron deficiency anaemia in patients with chronic kidney disease

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2018

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At a glance

  • Drugs Ferumoxytol (Primary)
  • Indications Iron deficiency anaemia
  • Focus Therapeutic Use

    • Most Recent Events

    • 03 Apr 2018 New trial record
    • 28 Mar 2018 In Dec 2016, the company proposed a protocol to FDA for a new pediatric study to satisfy post-approval commitments for feraheme. Following recent interactions with the FDA regarding the adequacy of proposed protocol, the company amended the protocol and intend to initiate a new pediatric study in the second quarter of 2018, According to AMAG Pharmaceuticals Form 10-K document.

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