/ Active, not recruitingPhase 3 在中国CKD-5HD患者中通过血液透析液长期给予Triferic的随机、安慰剂对照研究。
[Translation] A randomized, placebo-controlled study of long-term administration of Triferic via hemodialysis fluid in Chinese patients with CKD-5HD.
主要目的:
在中国CKD-5HD患者中确定Triferic经血液透析液长期给药在防止发生缺铁和维持红细胞生成及血红蛋白浓度所需铁供应方面的有效性与安全性。
[Translation] Primary objective: To determine the efficacy and safety of long-term administration of Triferic via hemodialysis fluid in preventing iron deficiency and maintaining iron supply required for erythropoiesis and hemoglobin concentration in Chinese CKD-5HD patients.
在健康中国成年志愿者中静脉给予Triferic(枸橼酸焦磷酸铁)的药代动力学试验
[Translation] Pharmacokinetic study of intravenously administered Triferic (ferric citrate pyrophosphate) in healthy Chinese adult volunteers
主要目的 测定在健康中国成年人中静脉(IV)给予Triferic铁的药代动力学。 次要目的 探索在健康中国成年人中静脉(IV)给予Triferic的安全性。
[Translation] Primary objective To determine the pharmacokinetics of intravenous (IV) iron Triferic in healthy Chinese adults. Secondary objective To explore the safety of intravenous (IV) Triferic in healthy Chinese adults.
在中国成年CKD-5 HD患者中Triferic(枸橼酸焦磷酸铁)的药代动力学试验
[Translation] Pharmacokinetic study of Triferic (ferric citrate pyrophosphate) in Chinese adult CKD-5 HD patients
主要目的 确定采用以下方式给药的Triferic铁的血清铁特征: 将27.2 mg Triferic铁添加至10 L碳酸氢盐浓缩液后经血液透析液(HD)给药4小时。 Triferic 6.5 mg Fe历时3小时透析器血液回路前给药 次要目的 探索在成年CKD-5 HD患者中Triferic 透析器前血液回路给药和HD给药的安全性
[Translation] Primary Objective To determine the serum iron profile of Triferic iron administered as follows: 27.2 mg Triferic iron added to 10 L bicarbonate concentrate administered via hemodialysis (HD) over 4 hours Triferic 6.5 mg Fe administered pre-dialyzer blood circuit over 3 hours Secondary Objective To explore the safety of pre-dialyzer blood circuit administration of Triferic and HD administration in adult CKD-5 HD patients
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