A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease

Trial Profile

A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Apr 2018

At a glance

  • Drugs Ferric maltol (Primary)
  • Indications Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms AEGIS CKD; AEGIS-3
  • Sponsors Iron Therapeutics; Shield Therapeutics
  • Most Recent Events

    • 06 Apr 2018 According to a Shield Therapeutics media release, FDA has provided guidance to progress submission of an NDA for Feraccru without conducting additional pivotal clinical trials. The NDA will be submitted as soon as possible in 2018.
    • 16 Mar 2018 According to a Shield Therapeutics media release, the company has presented data from revised analyses to the FDA. This analysis was performed using an amended statistical analysis plan that removed the confounding data from patients who were permitted in the study even after pre-specified events which could have led to withdrawal.
    • 16 Mar 2018 Results of a revised analyses published in the Shield Therapeutics Media Release
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