NCT01114139

A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 812 (actual)
• Sponsor: AMAG Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

Detailed description

This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study evaluated the safety and efficacy of ferumoxytol compared with placebo for the treatment of IDA, specifically in adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. The effect of ferumoxytol on hemoglobin, iron parameters and patient reported outcomes (PROs) compared with placebo was evaluated. Investigators were blinded to key laboratory parameters that could potentially unblind the treatment arms of the study, eg, hemoglobin \[Hgb\], hematocrit \[Hct\], iron, ferritin, total iron binding capacity \[TIBC\], and transferrin saturation \[TSAT\], and neither the Investigators nor the subjects were aware of their treatment assignment, hemoglobin or other laboratory values.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferumoxytol	IV Ferumoxytol
OTHER	Placebo	IV Placebo

Timeline

• Start date: 2010-06-19
• Primary completion: 2012-02-27
• Completion: 2012-10-22
• First posted: 2010-04-30
• Last updated: 2022-04-21
• Results posted: 2018-06-11

Locations

182 sites across 6 countries: United States, Canada, Hungary, India, Latvia, Poland