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在 IDA 和血液透析的 CKD 受试者中比较重复剂量的 Ferumoxytol 与铁蔗糖的疗效/安全性

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

Ferumoxytol 治疗 CKD 贫血试验 (FACT)：一项 IV 期、开放标签、多中心试验，采用 MRI 子研究，比较重复剂量的 Ferumoxytol 与蔗糖铁治疗 CKD 血液透析患者的 IDA

本研究的目的是比较重复静脉注射 (IV) ferumoxytol 和静脉注射蔗糖铁治疗依赖血液透析的 CKD 受试者 IDA 的疗效和安全性。

研究概览

地位

完全的

条件

干预/治疗

详细说明

这是一项 IV 期、随机、开放标签、活性对照、多中心临床试验，旨在评估与铁蔗糖相比，ferumoxytol 在 CKD 血液透析受试者中间歇性治疗 IDA 的安全性、有效性和使用频率1年期。 作为该主要研究的一部分，进行了氧化应激子研究和 MRI 子研究。 与主要研究的初始 TP 同时进行的氧化应激子研究旨在检查蔗糖铁和亚铁木糖醇在体外对接受血液透析的受试者诱导或不诱导氧化应激的不同程度。 MRI 子研究与主要研究同时进行并持续 11 个月，旨在评估心脏、肝脏和胰腺组织中铁沉积的可能性以及 2 年期间实验室参数的变化。

研究类型

介入性

注册 (实际的)

296

阶段

  • 第四阶段

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

  • 加拿大
      • Montréal、加拿大
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) , or speak with your personal physician
      • Montréal、加拿大
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Toronto、加拿大
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • 美国
    • Arkansas
      • Pine Bluff、Arkansas、美国、71603
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • California
      • Azusa、California、美国、91702
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Beverly Hills、California、美国、90211
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Los Angeles、California、美国、90022
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Los Angeles、California、美国、90095
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Lynwood、California、美国、90262
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Northridge、California、美国、91324
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Paramount、California、美国、90723
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Sacramento、California、美国、95815
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • San Diego、California、美国、92123
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • San Gabriel、California、美国、91776
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Simi Valley、California、美国、93065
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Whittier、California、美国、90603
        • For additional information regarding investigative sites for this trial , contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Whittier、California、美国、90603
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Connecticut
      • Middlebury、Connecticut、美国、06762
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Florida
      • Coral Springs、Florida、美国、33071
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Miami、Florida、美国、33186
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Georgia
      • Augusta、Georgia、美国、30904
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Macon、Georgia、美国、31217
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Kentucky
      • Louisville、Kentucky、美国、40292
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Shreveport、Louisiana、美国、71103
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Massachusetts
      • Framingham、Massachusetts、美国、01702
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Michigan
      • Pontiac、Michigan、美国、48341
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Roseville、Michigan、美国、48066
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Missouri
      • Farmington、Missouri、美国、63640
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • New York
      • Bronx、New York、美国、10641
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Brooklyn、New York、美国、11212
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Ridgewood、New York、美国、11385
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • North Carolina
      • Asheville、North Carolina、美国、28805
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Pennsylvania
      • Bethlehem、Pennsylvania、美国、18017
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Philadelphia、Pennsylvania、美国、19144
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • South Carolina
      • Columbia、South Carolina、美国、29209
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
    • Texas
      • Arlington、Texas、美国、76015
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Edinburg、Texas、美国、78539
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • Houston、Texas、美国、78238
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • San Antonio、Texas、美国、78205
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
      • San Antonio、Texas、美国、78229
        • For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
  • 英国
      • London、英国
        • For additional information regarding investigative sites for this trial , contact 1-877-411-2510 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 1-877-411-2510 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、OLDER_ADULT)

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. 慢性肾病的诊断
  3. 接受透析的受试者在筛选前必须已经接受透析至少 3 个月
  4. 具有生育潜力且性活跃的女性受试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. 对口服或静脉铁剂过敏史
  2. 怀孕或打算怀孕、哺乳、产后3个月内或血清或尿液妊娠试验阳性的女性受试者
  3. 筛选前 30 天内进行肠胃外铁剂治疗或筛选前 14 天内或计划在研究期间进行红细胞 (RBC)/全血输注

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：平行线
  • 屏蔽：没有任何

武器和干预

参与者组/臂
干预/治疗
实验性的：铁氧醇
静脉 (IV) 铁剂
药品：铁氧醇
IV Ferumoxytol
其他名称：
  • 铁血红素
ACTIVE_COMPARATOR：IV 铁蔗糖
静脉 (IV) 铁剂
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
血红蛋白变化
大体时间：多达 6 个治疗期（每个治疗期 5 周）
在每个治疗期中，ferumoxytol 和蔗糖铁在基线和第 5 周之间平均血红蛋白的变化。
多达 6 个治疗期（每个治疗期 5 周）

次要结果测量

结果测量
措施说明
大体时间
转铁蛋白饱和度 (TSAT) 的变化
大体时间：多达 6 个治疗期（每个治疗期 5 周）
每个 TP 从 TP 基线到第 5 周的 TSAT 平均变化
多达 6 个治疗期（每个治疗期 5 周）
每个 TP 从 TP 基线到第 5 周的任何时间血红蛋白增加 ≥ 1.0 g/dL 的受试者比例
大体时间：多达 6 个治疗期（每个治疗期 5 周）
在每 5 周治疗期间的任何时间点，各组受试者的血红蛋白增加≥1.0 g/dL 的比例。
多达 6 个治疗期（每个治疗期 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。

一般刊物

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)

2013年8月1日

初级完成 (实际的)

2016年2月1日

研究完成 (实际的)

2017年2月1日

研究注册日期

首次提交

2010年10月22日

首先提交符合 QC 标准的

2010年10月22日

首次发布 (估计)

2010年10月25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

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • AMAG-FER-CKD-401

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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