A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

Summary

To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).

Timeline

Start

2016-02-29

Primary completion

2017-01-16

Completion

2017-07-17

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Ferumoxytol vs Ferric Carboxymaltose (FCM); p = 0.0001; Treatment difference -0.10 (95% CI -0.80 to 0.61); Wald NCT02694978 ↗

Publications

• Background Adkinson NF, Strauss WE, Macdougall IC, Bernard KE, Auerbach M, Kaper RF, Chertow GM, Krop JS. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018 May;93(5):683-690. doi: 10.1002/ajh.25060. Epub 2018 Feb 24.
• Background Adkinson NF, Strauss WE, Bernard K, Kaper RF, Macdougall IC, Krop JS. Comparative safety of intravenous Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia: rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions. J Blood Med. 2017 Sep 26;8:155-163. doi: 10.2147/JBM.S142236. eCollection 2017.
• Wolf M, Chertow GM, Macdougall IC, Kaper R, Krop J, Strauss W. Randomized trial of intravenous iron-induced hypophosphatemia. JCI Insight. 2018 Dec 6;3(23):e124486. doi: 10.1172/jci.insight.124486.

Drugs

Indications