Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

Summary

Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.

Timeline

Start

2016-11-08

Primary completion

2018-03-28

Completion

2018-03-28

Outcome

Met primary endpoint

paper The co-primary safety objective was met, and no risk difference was observed between groups. PMID 31243803 ↗

paper The co-primary efficacy endpoint of non-inferiority in hemoglobin change was met PMID 31243803 ↗

Publications

• Results Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J Hematol. 2019 Sep;94(9):1007-1014. doi: 10.1002/ajh.25564. Epub 2019 Jul 13.
• Results Auerbach M and Lykke LL. A single infusion of iron isomaltoside 1000 allows a more rapid hemoglobin increment than multiple doses of iron sucrose with a similar safety profile in patients with iron deficiency anemia. Blood 2018 132:2334; doi: https://doi.org/10.1182/blood-2018-99-110199

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ferric derisomaltose	Unknown	1000 mg	Intravenous
Comparator	Iron sucrose	Unknown	200 mg	Intravenous

Indications