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Clinical Trial
. 2022 Nov;116(5):647-658.
doi: 10.1007/s12185-022-03401-0. Epub 2022 Jul 6.

Intravenous ferric derisomaltose versus saccharated ferric oxide for iron deficiency anemia associated with menorrhagia: a randomized, open-label, active-controlled, noninferiority study

Hiroshi Kawabata  1 , Takeshi Tamura  2 , Soichiro Tamai  3 , Akiko Fujibayashi  2 , Motoi Sugimura  4 ; Study Group
Collaborators, Affiliations
Clinical Trial

Intravenous ferric derisomaltose versus saccharated ferric oxide for iron deficiency anemia associated with menorrhagia: a randomized, open-label, active-controlled, noninferiority study

Hiroshi Kawabata et al. Int J Hematol. 2022 Nov.

Erratum in

Abstract

A multicenter, randomized, open-label, phase III study was conducted to compare the efficacy and safety of intravenous ferric derisomaltose (FDI) versus saccharated ferric oxide (SFO) in Japanese patients with iron deficiency anemia associated with menorrhagia. FDI can be administered as a single dose up to 1000 mg, whereas SFO has a maximum single dose of 120 mg. The primary endpoint, which was the maximum change in hemoglobin concentration from baseline, was noninferior for the FDI group compared with the SFO group. The incidence of treatment-emergent adverse events was lower in the FDI group (66.2%) than in the SFO group (90.8%). Notably, the incidence of serum phosphorus level < 2.0 mg/dL was significantly lower in the FDI group (8.4%) than in the SFO group (83.2%), and severe hypophosphatemia (≤ 1.0 mg/dL) occurred in 6.7% of SFO‑treated patients compared with none in the FDI group. The percentage of patients who achieved the cumulative total iron dose during the 8-week treatment period was higher in the FDI group (92.8%) than in the SFO group (43.2%). The study met its primary endpoint, and also demonstrated the tolerability of a high dose of FDI per infusion, with a lower incidence of hypophosphatemia.

Keywords: Ferric derisomaltose; Hypophosphatemia; Intravenous iron preparation; Iron deficiency anemia.

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Conflict of interest statement

Ferric derisomaltose was provided by Nippon Shinyaku Co., Ltd. Dr. H. Kawabata reports honoraria for lectures and consulting fees associated with his role in the submitted study as a medical officer from Nippon Shinyaku Co., Ltd. He is also a board member of the Japanese BioIron Society. Dr. M. Sugimura reports consulting fees associated with his role in the submitted study as a coordinating investigator from Nippon Shinyaku Co., Ltd. T. Tamura, S. Tamai, and A. Fujibayashi are employees of Nippon Shinyaku Co., Ltd.

Figures

Fig. 1
Fig. 1
Study design in Japanese female patients with iron deficiency anemia associated with menorrhagia. FDI ferric derisomaltose, R randomization, SFO saccharated ferric oxide, V visit, Vs screening visit, Vf1 follow-up visit 1, Vf2 follow-up visit 2.
Fig. 2
Fig. 2
Patient disposition
Fig. 3
Fig. 3
Laboratory value changes over the study period (mean ± SD) in (a) hemoglobin concentration (g/dL), (b) mean corpuscular volume (fL), (c) reticulocyte ratio (‰), (d) transferrin saturation (%), (e) serum ferritin concentration (ng/mL), and (f) serum hepcidin concentration (ng/mL). FDI ferric derisomaltose, SD standard deviation, SFO saccharated ferric oxide.
Fig. 4
Fig. 4
Laboratory value changes over the study period (mean ± SD) in serum phosphorus (mg/dL). FDI ferric derisomaltose, SD standard deviation, SFO saccharated ferric oxide.
See this image and copyright information in PMC

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