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比较 Ferumoxytol 与铁蔗糖治疗缺铁性贫血的试验

2022年3月31日 更新者：AMAG Pharmaceuticals, Inc.

比较 Ferumoxytol 与铁蔗糖治疗缺铁性贫血的 III 期、随机、开放标签、主动控制试验

该研究的目的是评估静脉注射 (IV) ferumoxytol 与静脉注射蔗糖铁治疗缺铁性贫血 (IDA) 的疗效和安全性。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

605

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Cherkasy、乌克兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Chernivtsi、乌克兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Donetsk、乌克兰、83045
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Donetsk、乌克兰、83114
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ivano-Frankivsk、乌克兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv、乌克兰、01030
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv、乌克兰、01034
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv、乌克兰、04050
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kyiv、乌克兰、04112
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Odessa、乌克兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Simferopol、乌克兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vinnytsya、乌克兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zaporizhzhya、乌克兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 匈牙利
      • Békéscsaba、匈牙利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gyula、匈牙利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Komárom、匈牙利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Miskolc、匈牙利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szekszárd、匈牙利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Szolnok、匈牙利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vác、匈牙利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zalaegerszeg、匈牙利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 南非
      • Cape Town、南非、7500
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Cape Town、南非、7530
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Durban、南非、4001
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Durban、南非、4091
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Roodepoort、南非
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Stellenbosch、南非
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 大韩民国
      • Cheonan、大韩民国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Daegu、大韩民国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Incheon、大韩民国、400-711
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Incheon、大韩民国、405-760
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul、大韩民国、110-774
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul、大韩民国、134-701
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul、大韩民国、135-710
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul、大韩民国、138-736
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul、大韩民国、158-710
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Seoul、大韩民国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Suwon、大韩民国、442-723
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Suwon、大韩民国、443-721
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 德国
      • Berlin、德国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Frankfurt、德国、60322
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Frankfurt、德国、60431
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mainz、德国、55131
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mainz、德国、D-55116
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Siegen、德国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wilhelmshaven、德国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 意大利
      • Padova、意大利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rozzano、意大利
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 拉脱维亚
      • Daugavpils、拉脱维亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga、拉脱维亚、LV-1002
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga、拉脱维亚、LV-1005
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga、拉脱维亚、LV-1006
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga、拉脱维亚、LV-1010
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Riga、拉脱维亚、LV-1013
        • For additional this triinformation regarding investigative sites for al, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ventspils、拉脱维亚、LV-3601
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ventspils、拉脱维亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 法国
      • La Tronche、法国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 波兰
      • Białystok、波兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Katowice、波兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kraków、波兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sopot、波兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Warszawa、波兰、02-341
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Warszawa、波兰、03-580
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Wrocław、波兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Zgierz、波兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Łęczyca、波兰
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 澳大利亚
      • Adelaide、澳大利亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ballarat、澳大利亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Concord、澳大利亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Five Dock、澳大利亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gosford、澳大利亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kingswood、澳大利亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Parkville、澳大利亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 立陶宛
      • Kaunas、立陶宛、LT-48259
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kaunas、立陶宛、LT-49449
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kaunas、立陶宛、LT-50009
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Kaunas、立陶宛、LT-50185
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Klaipėda、立陶宛
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vilnius、立陶宛、LT-03215
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Vilnius、立陶宛、LT-08661
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Šiauliai、立陶宛
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 罗马尼亚
      • Braşov、罗马尼亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bucharest、罗马尼亚、011422
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bucharest、罗马尼亚、020125
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Iaşi、罗马尼亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Suceava、罗马尼亚
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Timişoara、罗马尼亚、300158
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Timişoara、罗马尼亚、300593
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Târgu-Mureş、罗马尼亚、540136
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Târgu-Mureş、罗马尼亚、540461
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 英国
      • Cambridge、英国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • London、英国
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • 西班牙
      • Barcelona、西班牙
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Manresa、西班牙
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santa Cruz De Tenerife、西班牙
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Sevilla、西班牙
        • For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

主要纳入标准包括：

  1. ≥18岁的男性和女性

  2. IDA 的参与者定义为：

    1. 血红蛋白 <10.0 克/分升 (dL)
    2. 转铁蛋白饱和度 (TSAT) <20%
  3. 有口服铁剂治疗效果不佳或不能使用口服铁剂的参与者
  4. 具有生育潜力且性活跃的女性参与者必须在筛选前至少 1 个月采用有效的节育方法，并同意在完成参与研究之前继续节育

主要排除标准包括：

  1. IV 铁过敏史
  2. 对两类或更多类药物过敏
  3. 接受透析或估计肾小球滤过率 <30 mL/min(min)/1.73 的参与者 平方米 (m^2)
  4. 已怀孕、打算怀孕、正在哺乳、产后 2 周内或血清/尿液妊娠试验阳性的女性参与者
  5. 血红蛋白≤7.0 g/dL
  6. 血清铁蛋白 >600 纳克/mL

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：铁氧醇
参与者总共接受了 2 剂 IV ferumoxytol 510 毫克 (mg)（17 毫升 [mL]）。 第一剂 IV 510 mg 剂量在第 1 天（基线）给药，第二剂在第一剂后 2 至 8 (5±3) 天给药，总累积剂量为 1.02 克 (g)。
药品：铁氧醇
IV Ferumoxytol
其他名称：
  • 铁血红素
有源比较器：蔗糖铁
参与者在第 1 天（基线）和 14 天内的其他 4 个非连续日接受静脉注射或输注蔗糖铁 200 毫克（10 毫升），总累积剂量为 1.0 克。 按照一些国家/地区的包装说明书中的规定，首次接触 IV 蔗糖铁的参与者在接受第一剂剩余剂量之前在第一天接受了测试剂量。
药品：蔗糖铁
IV 铁蔗糖
其他名称：
  • 维诺弗

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
从基线到第 5 周的任何时间血红蛋白增加≥2.0 g/dL 的参与者
大体时间：基线（第 1 天）至第 5 周

显示从基线到第 5 周的任何时间血红蛋白增加 ≥ 2.0 g/dL 的参与者。 每位参与者从基线到第 5 周的任何时间的血红蛋白增加均基于以下计算：

血红蛋白变化 = 血红蛋白（第 X 周）- 血红蛋白（基线），其中第 X 周是直到并包括第 5 周的任何基线后访视。

基线定义为第 1 天的值（注射研究药物之前）。 第 1 天之前的筛选或最新值用于缺少第 1 天信息的任何参与者。 没有基线后血红蛋白值的参与者被归类为未达到 ≥ 2.0 g/dL 的增加。

仅对直至第 5 周的数据进行统计分析。
基线（第 1 天）至第 5 周

次要结果测量

结果测量
措施说明
大体时间
从基线到第 5 周的任何时间达到血红蛋白水平≥12.0 g/dL 的参与者
大体时间：基线（第 1 天）至第 5 周

从基线到第 5 周的任何时间达到 ≥ 12.0 g/dL 血红蛋白水平的参与者都会出现。 每位参与者从基线到第 5 周的任何时间的血红蛋白增加均基于以下计算：

血红蛋白变化 = 血红蛋白（第 X 周）- 血红蛋白（基线），其中第 X 周是直到并包括第 5 周的任何基线后访问。基线定义为第 1 天的值（注射研究药物之前）。 第 1 天之前的筛选或最新值用于缺少第 1 天信息的任何参与者。 没有任何基线后血红蛋白值的参与者被视为无反应者。
基线（第 1 天）至第 5 周
从基线到第 5 周血红蛋白的平均变化
大体时间：基线（第 1 天），第 5 周

每个参与者的血红蛋白从基线到第 5 周的平均变化计算如下：血红蛋白变化 = 血红蛋白（第 5 周）- 血红蛋白（基线）。

基线定义为第 1 天的值（注射研究药物之前）。 第 1 天之前的筛选或最新值用于缺少第 1 天信息的任何参与者。 如果缺少第 5 周的血红蛋白值，则相对于基线的变化被估算为零。
基线（第 1 天），第 5 周
TSAT 从基线到第 5 周的平均变化
大体时间：基线（第 1 天），第 5 周

每个参与者的 TSAT 从基线到第 5 周的平均变化计算为：TSAT 变化 = TSAT（第 5 周）- TSAT（基线）。

基线定义为第 1 天的值（注射研究药物之前）。 第 1 天之前的筛选或最新值用于缺少第 1 天信息的任何参与者。 如果缺少第 5 周的 TSAT 值，则相对于基线的变化被推算为零。
基线（第 1 天），第 5 周
慢性疾病治疗功能评估 (FACIT) 的平均变化 - 从基线到第 5 周的疲劳评分
大体时间：基线（第 1 天），第 5 周

FACIT-疲劳问卷是一份包含 13 个项目的问卷，其设计和验证旨在专门评估治疗对疲劳和相关症状（如疲倦）的存在和影响，以及对患有癌症的贫血参与者的健康相关生活质量的影响。 问卷有 13 个项目，每个项目均采用 4 点李克特量表进行测量。 评分范围从 0（最疲劳）到 52（最不疲劳）分，分数越高表示功能越好或疲劳程度越低。

FACIT-疲劳评分从基线到第 5 周的平均变化为每个参与者计算如下：

FACIT-疲劳分数变化 = FACIT-疲劳分数（第 5 周）- FACIT-疲劳分数（基线）。

基线定义为第 1 天的值（研究药物首次给药前）。第 1 天之前的筛选值或最近的值用于缺少第 1 天信息的任何参与者。 如果缺少第 5 周 FACIT-疲劳评分值，则相对于基线的变化被估算为零。
基线（第 1 天），第 5 周
从基线到血红蛋白增加≥2.0 g/dL 或血红蛋白值≥12.0 g/dL 的时间
大体时间：从基线（第 1 天）到第 5 周
血红蛋白增加 ≥ 2.0 g/dL 或血红蛋白值 ≥ 12.0 g/dL 的时间定义为从基线（第 1 天）到参与者血红蛋白首次增加 ≥ 2.0 g/dL 或血红蛋白的天数≥12.0 g/dL 的值，并使用 Kaplan-Meier 曲线计算。 没有血红蛋白增加 ≥ 2.0 g/dL 或血红蛋白水平 ≥ 12.0 g/dL 的参与者在他们的最后访问日被审查。 没有任何基线后研究访问的参与者不包括在内。
从基线（第 1 天）到第 5 周

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AMAG Pharmaceuticals, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2010年8月10日

初级完成 (实际的)

2011年11月9日

研究完成 (实际的)

2012年6月25日

研究注册日期

首次提交

2010年4月29日

首先提交符合 QC 标准的

2010年4月30日

首次发布 (估计)

2010年5月3日

研究记录更新

最后更新发布 (实际的)

2022年4月21日

上次提交的符合 QC 标准的更新

2022年3月31日

最后验证

2022年3月1日

更多信息

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其他研究编号

  • AMAG-FER-IDA-302

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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