Division of Nephrology and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Kanagawa, Japan.
Sci Rep. 2019 Jun 20;9(1):8877. doi: 10.1038/s41598-019-45335-4.
Ferric citrate hydrate (FC) is an iron-based phosphate binder approved for hyperphosphataemia in patients with chronic kidney disease. We conducted a randomised controlled trial to evaluate the effects of FC on anaemia management in haemodialysis patients with hyperphosphataemia. We 1:1 randomised 93 patients who were undergoing haemodialysis and being treated with non-iron-based phosphate binders and erythropoiesis-stimulating agents (ESA) to receive 24 weeks of FC or to continue their non-iron-based phosphate binders (control) in a multicentre, open-label, parallel-design. Phosphate level was controlled within target range (3.5-6.0 mg/dL). The primary endpoint was change in ESA dose from baseline to end of treatment. Secondary endpoints were changes in red blood cell, iron and mineral, and bone-related parameters. Compared with control, FC reduced ESA dose [mean change (SD), -1211.8 (3609.5) versus +1195 (6662.8) IU/week; P = 0.03] without significant differences in haemoglobin. FC decreased red blood cell distribution width (RDW) compared with control. While there were no changes in serum phosphate, FC reduced C-terminal fibroblast growth factor (FGF) 23 compared with control. The incidence of adverse events did not differ significantly between groups. Despite unchanged phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23 compared with control.
柠檬酸铁铵（FC）是一种铁基磷酸盐结合剂，已被批准用于治疗慢性肾脏病患者的高磷血症。我们进行了一项随机对照试验，以评估 FC 对高磷血症血液透析患者贫血管理的影响。我们将 93 名正在接受血液透析且正在接受非铁基磷酸盐结合剂和红细胞生成刺激剂（ESA）治疗的患者以 1:1 的比例随机分为 FC 组（接受 24 周的 FC 治疗）或继续使用非铁基磷酸盐结合剂（对照组），试验采用多中心、开放标签、平行设计。将磷水平控制在目标范围内（3.5-6.0mg/dL）。主要终点是从基线到治疗结束时 ESA 剂量的变化。次要终点是红细胞、铁和矿物质以及与骨骼相关参数的变化。与对照组相比，FC 降低了 ESA 剂量[平均变化（SD），-1211.8（3609.5）与+1195（6662.8）IU/周；P=0.03]，而血红蛋白没有显著差异。FC 降低了红细胞分布宽度（RDW），而对照组则没有变化。尽管血清磷没有变化，但 FC 降低了 C 末端成纤维细胞生长因子（FGF）23，与对照组相比。两组不良事件的发生率无显著差异。尽管磷酸盐和血红蛋白水平保持不变，但与对照组相比，FC 降低了 ESA 剂量、RDW 和 C 末端 FGF23。
