A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial

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A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial

Auerbach et al., 2019 | Am J Hematol | Rct

Citation

Auerbach Michael, Henry David, ... Glaspy John. 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

Abstract

Iron deficiency anemia (IDA) is prevalent, and intravenous iron, especially if given in a single dose, may result in better adherence compared with oral iron. The present trial (FERWON-IDA) is part of the FERWON program with iron isomaltoside 1000/ferric derisomaltose (IIM), evaluating safety and efficacy of high dose IIM in IDA patients of mixed etiologies. This was a randomized, open-label, comparative, multi-center trial conducted in the USA. The IDA patients were randomized 2:1 to a single dose of 1000 mg IIM, or iron sucrose (IS) administered as 200 mg intravenous injections, up to five times. The co-primary endpoints were adjudicated serious or severe hypersensitivity reactions, and change in hemoglobin from baseline to week eight. A total of 1512 patients were enrolled. The frequency of patients with serious or severe hypersensitivity reactions was 0.3% (95% confidence interval: 0.06;0.88) vs 0.4% (0.05;1.45) in the IIM and IS group, respectively. The co-primary safety objective was met, and no risk difference was observed between groups. The co-primary efficacy endpoint of non-inferiority in hemoglobin change was met, and IIM led to a significantly more rapid hematological response in the first two weeks. The frequency of cardiovascular events was 0.8% and 1.2% in the IIM and IS group, respectively (P = .570). The frequency of hypophosphatemia was low in both groups. Iron isomaltoside administered as 1000 mg resulted in a more rapid and more pronounced hematological response, compared with IS, which required multiple visits. The safety profile was similar with a low frequency of hypersensitivity reactions and cardiovascular events.

Key Findings

The safety profile was similar with a low frequency of hypersensitivity reactions and cardiovascular events.

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population serious or severe hypersensitivity
Sample Size 1512
Age Range See abstract
Condition deficiency

MeSH Terms

  • Adult
  • Anemia, Iron-Deficiency
  • Disaccharides
  • Female
  • Ferric Compounds
  • Ferric Oxide, Saccharated
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies

Evidence Classification

  • Level: Rct
  • Publication Types: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
  • Vertical: iron-pregnancy

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09