Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

Summary

The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).

Timeline

Start

2017-10-30

Primary completion

2018-05-29

Completion

2018-05-29

Outcome

Met primary endpoint

registry analysis (superiority test); Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose; p <0.0001; Risk Difference (RD) -65.8 (95% CI -76.6 to -49.8); Cochran-Mantel-Haenszel NCT03237065 ↗

paper The incidence of hypophosphatemia was significantly lower following iron isomaltoside vs ferric carboxymaltose PMID 32016310 ↗

Publications

• Results Wolf M, Rubin J, Achebe M, Econs M, Peacock M, Imel E, Thomsen L, Carpenter T, Weber T, Zoller H. Effects of iron isomaltoside versus ferric carboxymaltose on hormonal control of phosphate homeostasis: The PHOSPHARE-IDA04/05 randomized controlled trials. Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, OR13-3, https://doi.org/10.1210/js.2019-OR13-3
• Wolf M, Rubin J, Achebe M, Econs MJ, Peacock M, Imel EA, Thomsen LL, Carpenter TO, Weber T, Brandenburg V, Zoller H. Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia: Two Randomized Clinical Trials. JAMA. 2020 Feb 4;323(5):432-443. doi: 10.1001/jama.2019.22450.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ferric carboxymaltose	Other / unclassified	750 mg	Intravenous
Subject	Ferric derisomaltose	Unknown	1000 mg	Intravenous

Indications