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一项针对糖尿病肾病参与者的研究

2019年9月9日 更新者：Eli Lilly and Company

一项随机、双盲、安慰剂对照、多中心、2 期研究，以评估 LY2382770 在 1 型或 2 型糖尿病引起的糖尿病肾病患者中的安全性和肾脏疗效

本研究的目的是确定 LY2382770 在保护糖尿病肾病参与者的肾功能方面是否安全有效。

研究概览

地位

终止

条件

干预/治疗

详细说明

主要目的是确定在接受血管紧张素转换酶抑制剂 (ACEi) 或血管紧张素 II 受体阻滞剂 (ARB) 治疗的参与者中，LY2382770 在延缓糖尿病肾病进展方面是否比安慰剂更有效，为期 1 年，每月给药一次.

研究类型

介入性

注册 (实际的)

417

阶段

  • 阶段2

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

  • 以色列
      • Ashkelon、以色列、78278
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      • Hadera、以色列、38100
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      • Haifa、以色列、31096
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      • Holon、以色列、58100
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      • Jerusalem、以色列、91120
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      • Kfar Saba、以色列、44281
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      • Nahariya、以色列、22100
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      • Rehovot、以色列、76100
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      • Safed、以色列、13110
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      • Tel Aviv、以色列、64239
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      • Tel Hashomer、以色列、52621
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      • Zerifin、以色列、70300
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  • 匈牙利
      • Baja、匈牙利、6500
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      • Balatonfured、匈牙利、8230
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      • Budapest、匈牙利、1096
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gyongyos、匈牙利、3200
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      • Gyor、匈牙利、9023
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      • Kaposvar、匈牙利、7400
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      • Nagykanizsa、匈牙利、8800
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      • Szeged、匈牙利、6720
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      • Szigetvar、匈牙利、7900
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      • Zalaegerszeg、匈牙利、8900
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  • 捷克语
      • Cesky Krumlov、捷克语、381 27
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      • Decin、捷克语、405 99
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      • Jilemnice、捷克语、514 15
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      • Liberec、捷克语、460 63
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      • Ostrava、捷克语、703 84
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      • Prague、捷克语、181 02
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      • Tabor、捷克语、390 02
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      • Teplice、捷克语、415 01
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  • 法国
      • Grenoble、法国、38043
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      • Lyon、法国、69437
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      • Nanterre Cedex、法国、92014
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      • Valenciennes、法国、59322
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      • Vandoeuvre Les Nancy、法国、54511
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  • 波多黎各
      • Cidra、波多黎各、00739
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      • Rio Piedras、波多黎各、000935
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  • 澳大利亚
    • New South Wales
      • Camperdown、New South Wales、澳大利亚、2050
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      • Concord、New South Wales、澳大利亚、2139
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Gosford、New South Wales、澳大利亚、2250
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Liverpool、New South Wales、澳大利亚、2170
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Tasmania
      • Launceston、Tasmania、澳大利亚、7250
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Victoria
      • Box Hill、Victoria、澳大利亚、3128
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Fitzroy、Victoria、澳大利亚、3065
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      • Heidelberg、Victoria、澳大利亚、3084
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      • Melbourne、Victoria、澳大利亚、3004
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      • Parkville、Victoria、澳大利亚、3050
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      • Reservoir、Victoria、澳大利亚、3073
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    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
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  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85012
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • California
      • Inglewood、California、美国、90301
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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、90073
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Denver、Colorado、美国、80220
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Port Charlotte、Florida、美国、33952
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tampa、Florida、美国、33614
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    • Georgia
      • Atlanta、Georgia、美国、30342
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Idaho
      • Idaho Falls、Idaho、美国、83404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Kansas
      • Wichita、Kansas、美国、67214
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Louisiana
      • Kenner、Louisiana、美国、70065
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Maryland
      • Rockville、Maryland、美国、20852
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • Kansas City、Missouri、美国、64128
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Nebraska
      • Omaha、Nebraska、美国、68131
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    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Charlotte、North Carolina、美国、28207
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      • Durham、North Carolina、美国、27705
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      • Greenville、North Carolina、美国、27834
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      • Winston-Salem、North Carolina、美国、27157
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    • Ohio
      • Beachwood、Ohio、美国、44122
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    • Oregon
      • Bend、Oregon、美国、97701
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • South Carolina
      • Orangeburg、South Carolina、美国、29118
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Dallas、Texas、美国、75390
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      • Lufkin、Texas、美国、75904
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    • Utah
      • Saint George、Utah、美国、84770
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Virginia
      • Suffolk、Virginia、美国、23435
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53295
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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

25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：

  • 因 1 型或 2 型糖尿病而推测患有慢性肾病的参与者
  • 具有一定肾功能水平的参与者 - 女性血清肌酐 (SCr) 为 1.3 至 3.3 mg/dl（115 至 291 微摩尔/升），男性为 1.5 至 3.5 毫克/分升（132 至 309 微摩尔/升），或估计肾小球滤过率 (eGFR) 20 至 60 mL/min/1.73 平方米
  • 尿蛋白的参与者 - 24 小时尿蛋白/肌酐比值 (PCR) 大于或等于 800 mg/g（大于或等于 91 mg/mmol）。
  • 参与者必须服用稳定且可接受剂量的 ACE（血管紧张素转换酶）抑制剂或 ARB（血管紧张素 II 受体阻滞剂），否则无法耐受这些药物。

主要排除标准：

  • 可能怀孕、正在怀孕或正在哺乳的女性参与者

  • 具有以下任何一种健康状况的参与者（现场研究人员将讨论这些标准并确定参与者的参与能力）

    • 慢性炎症或自身免疫性疾病
    • 由糖尿病以外的原因引起的慢性肾脏病
    • 器官移植
    • 血压过高
    • 病毒性乙型或丙型肝炎肝脏感染、肝硬化或严重的肝脏疾病
    • 近期消化道出血
    • 筛选前 3 个月内发生急性肾损伤
    • 筛选前 3 个月内进行过大手术或计划在研究期间进行
    • HIV 感染——导致 AIDS 的病毒
    • 不稳定的心脏病
    • 最近发生的癌症或其他导致患癌症风险过高的疾病
    • 需要服用改变免疫系统的药物

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：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：安慰剂
每月皮下注射一次，持续 12 个月
实验性的：2 毫克 LY2382770
药品：LY2382770
每月皮下注射一次，持续 12 个月
实验性的：10 毫克 LY2382770
药品：LY2382770
每月皮下注射一次，持续 12 个月
实验性的：50 毫克 LY2382770
药品：LY2382770
每月皮下注射一次，持续 12 个月

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 12 个月终点的对数转换 (In) 血清肌酐的变化
大体时间：基线，12 个月
使用协方差分析 (ANCOVA) 模型，将治疗、访视和治疗-访视相互作用作为固定效应，受试者作为随机效应，基线血清肌酐对数转换 (ln) 和第一次晨尿蛋白与肌酐比值 (PCR) 对数将 (ln) 转换为协变量。
基线，12 个月

次要结果测量

结果测量
措施说明
大体时间
从基线到 12 个月终点的对数转换 (ln) 尿蛋白/肌酐比率的变化
大体时间：基线，12 个月
使用协方差分析 (ANCOVA) 模型，将治疗、访视和治疗-访视相互作用作为固定效应，受试者作为随机效应，基线血清肌酐对数转换 (ln) 和第一次晨尿蛋白与肌酐比值 (PCR) 对数将 (ln) 转换为协变量。
基线，12 个月
群体药代动力学 (PK) - 给药间隔内浓度-时间曲线下的模型估计面积 (AUC)
大体时间：至 12 个月的基线（每月一次在给药前和/或给药后收集样本）
至 12 个月的基线（每月一次在给药前和/或给药后收集样本）
从基线到 12 个月的对数转换 (ln) 血清肌酐变化斜率
大体时间：通过 12 个月的基线
使用协方差分析 (ANCOVA) 模型，治疗作为固定效应，基线血清肌酐对数转换 (ln) 和第一次晨尿蛋白与肌酐比值 (PCR) 对数转换 (ln) 作为协变量。
通过 12 个月的基线
估计肾小球滤过率 (eGFR) 从基线到 12 个月的变化斜率
大体时间：通过 12 个月的基线
使用协方差分析 (ANCOVA) 模型，治疗作为固定效应，基线血清肌酸酐对数转换 (ln) 和第一次晨尿蛋白与肌酸酐比 (PCR) 对数转换 (ln) 作为协变量。
通过 12 个月的基线

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

Eli Lilly and Company

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

2010年7月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2010年4月28日

首先提交符合 QC 标准的

2010年4月28日

首次发布 (估计)

2010年4月30日

研究记录更新

最后更新发布 (实际的)

2019年9月17日

上次提交的符合 QC 标准的更新

2019年9月9日

最后验证

2019年9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

  • 10168 (注册表标识符：DAIDS ES)
  • H9V-MC-GFRF (其他标识符：Eli Lilly and Company)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在批准研究计划和签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。

IPD 共享时间框架

在美国和欧盟研究的适应症首次公布和批准后 6 个月（以较晚者为准）可提供数据。 数据将无限期地可供请求。

IPD 共享访问标准

研究提案必须得到独立审查小组的批准，研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 临床研究报告（CSR）

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.

安慰剂的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

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条件

罕见疾病

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