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

Iron Deficiency Anemia Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01114139
Study type Interventional
Source AMAG Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 3
Start date June 19, 2010
Completion date October 22, 2012
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