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Abstract：
BACKGROUND: Roxadustat is an oral hypoxia inducing factor-prolyl hydroxylase inhibitor (HIF-PHI) that regulates iron metabolism in patients with chronic kidney disease (CKD) primarily by reducing hepcidin levels and mobilizing internal iron stores. More data are needed to demonstrate the efficacy of roxadustat in regulating iron metabolism in patients with peritoneal dialysis (PD) compared with erythropoiesis stimulating agents (ESAs).
METHODS: This prospective cohort study enrolled PD patients with a mean hemoglobin level of 60-100 g/L. All subjects were randomized into two groups at a ratio of 2:1 the roxadustat group (106 cases), and the ESA group (53 cases). The primary endpoint was the change in the iron biomarker levels and the proportion of patients with absolute iron deficiency and functional iron deficiency.
RESULTS: Compared with ESAs, roxadustat significantly decreased hepcidin level (difference, - 20.09 ng/mL; 95% CI, - 30.26 to - 9.92), attenuated the increase in serum soluble transferrin receptor (sTFR) level (difference, - 7.87 nmol/L; 95% CI, - 12.11 to - 3.64), and reduced the proportion of patients with functional iron deficiency (roxadustat, 11.43%; ESA, 33.33%). There was no significant difference in safety of the two groups over the duration of the study.
CONCLUSIONS: Compared with ESA group, roxadustat group showed significant differences in all iron biomarker levels except serum ferritin (sFt) and transferrin saturation (TSAT). These results suggest that roxadustat was superior to ESAs as a therapy for iron metabolism in PD patients.
BACKGROUND: This study completed Chinese Clinical Trial Registration on March 4, 2022 (registration number: ChiCTR2200057231).
METHODS: This prospective cohort study enrolled PD patients with a mean hemoglobin level of 60-100 g/L. All subjects were randomized into two groups at a ratio of 2:1 the roxadustat group (106 cases), and the ESA group (53 cases). The primary endpoint was the change in the iron biomarker levels and the proportion of patients with absolute iron deficiency and functional iron deficiency.
RESULTS: Compared with ESAs, roxadustat significantly decreased hepcidin level (difference, - 20.09 ng/mL; 95% CI, - 30.26 to - 9.92), attenuated the increase in serum soluble transferrin receptor (sTFR) level (difference, - 7.87 nmol/L; 95% CI, - 12.11 to - 3.64), and reduced the proportion of patients with functional iron deficiency (roxadustat, 11.43%; ESA, 33.33%). There was no significant difference in safety of the two groups over the duration of the study.
CONCLUSIONS: Compared with ESA group, roxadustat group showed significant differences in all iron biomarker levels except serum ferritin (sFt) and transferrin saturation (TSAT). These results suggest that roxadustat was superior to ESAs as a therapy for iron metabolism in PD patients.
BACKGROUND: This study completed Chinese Clinical Trial Registration on March 4, 2022 (registration number: ChiCTR2200057231).
摘要：
背景：Roxadustat是一种口服缺氧诱导因子-脯氨酸酰羟化酶抑制剂（HIF-PHI），主要通过降低铁调素水平和动员内部铁储备来调节慢性肾病（CKD）患者的铁代谢。与红细胞生成刺激剂（ESA）相比，需要更多的数据来证明罗沙司他在调节腹膜透析（PD）患者铁代谢方面的功效。
方法：这项前瞻性队列研究招募了平均血红蛋白水平为60-100g/L的PD患者。所有受试者以2：1的比例随机分为两组，罗沙司他组（106例），和ESA组（53例）。主要终点是铁生物标志物水平的变化以及绝对铁缺乏和功能性铁缺乏患者的比例。
结果：与ESA相比，罗沙他显著降低铁调素水平(差异，-20.09ng/mL；95%CI，-30.26至-9.92），降低了血清可溶性转铁蛋白受体（sTFR）水平的升高（差异，-7.87nmol/L；95%CI，-12.11至-3.64），并降低了功能性缺铁患者的比例(罗沙司，11.43%；欧空局，33.33%）。在研究期间，两组的安全性没有显着差异。
结论：与欧空局组相比，罗沙司他组除了血清铁蛋白(sFt)和转铁蛋白饱和度(TSAT)外，所有铁生物标志物水平均有显著差异。这些结果表明，罗沙司他作为PD患者铁代谢的疗法优于ESA。
背景：本研究于2022年3月4日完成中国临床试验注册（注册号：ChiCTR2200057231）。
方法：这项前瞻性队列研究招募了平均血红蛋白水平为60-100g/L的PD患者。所有受试者以2：1的比例随机分为两组，罗沙司他组（106例），和ESA组（53例）。主要终点是铁生物标志物水平的变化以及绝对铁缺乏和功能性铁缺乏患者的比例。
结果：与ESA相比，罗沙他显著降低铁调素水平(差异，-20.09ng/mL；95%CI，-30.26至-9.92），降低了血清可溶性转铁蛋白受体（sTFR）水平的升高（差异，-7.87nmol/L；95%CI，-12.11至-3.64），并降低了功能性缺铁患者的比例(罗沙司，11.43%；欧空局，33.33%）。在研究期间，两组的安全性没有显着差异。
结论：与欧空局组相比，罗沙司他组除了血清铁蛋白(sFt)和转铁蛋白饱和度(TSAT)外，所有铁生物标志物水平均有显著差异。这些结果表明，罗沙司他作为PD患者铁代谢的疗法优于ESA。
背景：本研究于2022年3月4日完成中国临床试验注册（注册号：ChiCTR2200057231）。
