Block Geoffrey A, Mizani Mohammed Reza, Broumand Varshasb, Newby F David, Erinle Ayodele, Arias Carolina, Block Martha, Brillhart Stephanie, Leppink Amanda, Danese Mark, Dittrich Mary
US Renal Care, Plano, Texas, USA.
South Texas Renal Care Group, San Antonio, Texas, USA.
Am J Nephrol. 2024;55(5):520-528. doi: 10.1159/000540227. Epub 2024 Jul 15.
Ferric citrate (FC) is an FDA-approved iron-based phosphate binder for adults with dialysis-dependent chronic kidney disease. This study investigated the impact of FC as the primary phosphate-lowering therapy on utilization of erythropoiesis-stimulating agents (ESAs) and intravenous (IV) iron.
In this randomized, open-label, active-controlled, multicenter study (NCT04922645), patients on dialysis and receiving ESAs were randomized to receive FC or remain on standard of care (SOC) phosphate-lowering therapy for up to 6 months. Primary endpoints were the difference in change from baseline to efficacy evaluation period (EEP) in mean monthly ESA and IV iron doses. Secondary endpoints included treatment differences in hemoglobin, phosphate, TSAT, and ferritin levels.
Two hundred nine patients were randomized to FC and had a day 1 dosing visit (n = 103) or SOC (n = 106). The two groups had similar baseline laboratory characteristics; however, atherosclerotic CV disease, peripheral vascular disease, and congestive heart failure were more common in the SOC group. The mean treatment difference in ESA monthly dose was -30.8 μg (FC vs. SOC; p = 0.02). An absolute though non-statistically significant change in mean monthly IV iron dose of -37.2 mg (p = 0.17) was observed with FC. Mean hemoglobin, TSAT, and ferritin all increased from baseline to the EEP with FC versus SOC. Serious adverse events occurred in 28% of patients receiving FC versus 37% in those receiving SOC.
In patients receiving dialysis, treatment with FC as compared to remaining on SOC phosphate binders resulted in reductions in mean monthly ESA and IV iron dose.
柠檬酸铁（FC）是一种经美国食品药品监督管理局（FDA）批准的用于依赖透析的成年慢性肾脏病患者的铁基磷酸盐结合剂。本研究调查了FC作为主要的降磷疗法对促红细胞生成素（ESA）和静脉注射铁剂使用的影响。
在这项随机、开放标签、活性对照、多中心研究（NCT04922645）中，接受ESA治疗的透析患者被随机分配接受FC治疗或继续接受标准护理（SOC）降磷疗法，为期6个月。主要终点是从基线到疗效评估期（EEP）平均每月ESA和静脉注射铁剂剂量的变化差异。次要终点包括血红蛋白、磷酸盐、转铁蛋白饱和度（TSAT）和铁蛋白水平的治疗差异。
209名患者被随机分配至FC组，并进行了第1天给药访视（n = 103）或SOC组（n = 106）。两组具有相似的基线实验室特征；然而，动脉粥样硬化性心血管疾病、外周血管疾病和充血性心力衰竭在SOC组中更为常见。ESA每月剂量的平均治疗差异为-30.8μg（FC组对比SOC组；p = 0.02）。使用FC观察到平均每月静脉注射铁剂剂量有-37.2mg的绝对变化（p = 0.17），但无统计学意义。与SOC组相比，FC组从基线到EEP时平均血红蛋白、TSAT和铁蛋白均升高。接受FC治疗的患者中有28%发生严重不良事件，而接受SOC治疗的患者中这一比例为37%。
在接受透析的患者中，与继续使用SOC磷酸盐结合剂相比，使用FC治疗可降低平均每月ESA和静脉注射铁剂剂量。
