Long-term safety and efficacy of ferric citrate in phosphate-lowering and iron-repletion effects among patients with on hemodialysis: A multicenter, open-label, Phase IV trial.
Long-term safety and efficacy of ferric citrate in phosphate-lowering and iron-repletion effects among patients with on hemodialysis: A multicenter, open-label, Phase IV trial.
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DOI：
10.1371/journal.pone.0264727
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
Tarng DC
中科院分区：
文献类型：
--
作者：
Lee CT;Lee CC;Wu MJ;Chiu YW;Leu JG;Wu MS;Peng YS;Wu MS;Tarng DC
我们探讨了柠檬酸铁在台湾血液透析患者中的长期安全性和有效性，并进一步评估了不同基线组的铁补充效果和铁参数的变化。这是一项为期12个月、IV期、多中心、开放标签研究。柠檬酸铁的初始剂量根据患者的临床状况给予，并进一步调整以维持血清磷在3.5-5.5 mg/dL。主要终点是评估枸橼酸铁的安全性特征。次要终点是通过时程变化和达到血磷目标范围的受试者数量来评价疗效。共入组202例患者。未观察到明显或非预期的安全性问题。最常见的治疗后出现的不良事件为胃肠道相关的粪便变色（41.6%）。血磷控制良好，平均剂量为3.35±1.49 g/天，范围为1.5 - 6.0 g/天。铁参数显著改善。铁蛋白和TSAT较基线的变化分别为227.17 ng/mL和7.53%（p趋势<0.001），治疗3-6个月后增加开始减缓。此外，仅在铁蛋白（≤500 ng/mL）和TSAT（<30%）基线水平较低的患者中发现增加趋势。柠檬酸铁是一种有效的磷结合剂，在ESRD患者中具有良好的安全性。柠檬酸铁补铁是有效的，并且在基线较高的患者中增加有限。除了控制高磷酸盐血症外，柠檬酸铁还显示出治疗肾性贫血的额外益处。ClinicalTrials.gov ID：NCT 03256838; 2017年4月12日。
We explored the long-term safety and efficacy of ferric citrate in hemodialysis patients in Taiwan, and further evaluated the iron repletion effect and change of iron parameters by different baseline groups. This was a 12-month, Phase IV, multicenter, open-label study. The initial dose of ferric citrate was administered by patients’ clinical condition and further adjusted to maintain serum phosphorus at 3.5–5.5 mg/dL. The primary endpoint was to assess the safety profiles of ferric citrate. The secondary endpoints were to evaluate the efficacy by the time-course changes and the number of subjects who achieved the target range of serum phosphorus. A total of 202 patients were enrolled. No apparent or unexpected safety concerns were observed. The most common treatment-emergent adverse events were gastrointestinal-related with discolored feces (41.6%). Serum phosphorus was well controlled, with a mean dose of 3.35±1.49 g/day, ranging from 1.5 to 6.0 g/day. Iron parameters were significantly improved. The change from baseline of ferritin and TSAT were 227.17 ng/mL and 7.53%, respectively (p-trend<0.001), and the increase started to slow down after 3–6 months of treatment. In addition, the increase trend was found only in patients with lower baseline level of ferritin (≤500 ng/mL) and TSAT (<30%). Ferric citrate is an effective phosphate binder with favorable safety profile in ESRD patients. The iron-repletion by ferric citrate is effective, and the increase is limited in patients with a higher baseline. In addition to controlling hyperphosphatemia, ferric citrate also shows additional benefits in the treatment of renal anemia. ClinicalTrials.gov ID: NCT03256838; 12/04/2017.
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