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.

进行了一项多中心、随机、开放标签的 III 期研究，以比较静脉注射去甲基麦芽糖铁 (FDI) 与糖化氧化铁 (SFO) 在日本缺铁性贫血伴月经过多患者中的疗效和安全性。FDI 可以单剂量给药，最高可达 1000 毫克，而 SFO 的最大单剂量为 120 毫克。主要终点是血红蛋白浓度相对于基线的最大变化，与 SFO 组相比，FDI 组不劣于 SFO 组。FDI 组（66.2%）治疗中出现的不良事件发生率低于 SFO 组（90.8%）。值得注意的是，FDI组血清磷水平<2.0 mg/dL的发生率（8.4%）明显低于SFO组（83.2%），6例发生严重低磷血症（≤1.0 mg/dL）。与 FDI 组相比，7% 的 SFO 治疗患者没有。FDI 组（92.8%）在 8 周治疗期间达到累积总铁剂量的患者百分比高于 SFO 组（43.2%）。该研究达到了其主要终点，并且还证明了每次输注高剂量 FDI 的耐受性，低磷血症的发生率较低。