儿童肾移植损伤和肾素-血管紧张素系统 (RETASK) (RETASK)
2017年11月6日 更新者：Wake Forest University Health Sciences
在儿科肾移植患者中，排斥反应、药物毒性和缺血会导致早期和慢性肾同种异体移植物损伤，从而缩短移植物寿命和患者存活率。
早期发现损伤将有助于预防和治疗。
金标准监测活检有局限性，包括延迟发现损伤。
没有非侵入性测试可以在临床明显之前识别移植物损伤。
该项目的目标是开发一种新的亚临床移植物损伤早期标记物，以促进及时识别和治疗。
研究概览
详细说明
肾脏损伤会激活传统的肾素-血管紧张素 (Ang) 系统 (RAS)，其特征在于血管紧张素转换酶 (ACE)/Ang II/Ang II 1 型受体。
Ang 转换酶 2 (ACE2)/Ang-(1-7)/Mas 通路可抵消这种损伤。
ACE/Ang II 和 ACE2/Ang-(1-7) 通路水平之间的平衡或比率在临床上可能很重要，因为 Ang-(1-7) 抵消了 Ang II 介导的损伤。
肾小管细胞上 ACE 和 Ang II 表达的增加以及 ACE2 和 Ang-(1-7) 表达的减少可能促进肾损伤。
肾小管损伤可能会增加保护性 ACE2 和 Ang-(1-7) 的尿液流失，通过允许 ACE 和 Ang II 无对抗地刺激炎症和纤维化来传播肾损伤。
研究人员的假设是，尿液 ACE-to-ACE2 和 Ang II-to-Ang-(1-7) 比率向 ACE2 和 Ang-(1-7) 的转变预测肾活检诊断的急性移植物损伤并预测慢性肾活检移植物损伤。
研究类型
观察性的
注册 (实际的)
29
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
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North Carolina
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University Baptist Medical Center
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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
1年 至 20年 (成人、孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
这是一项观察性研究，使用从 Lucile Packard 儿童医院肾移植评估门诊招募的方便样本患者。
描述
纳入标准：
- 1 - 20 岁
- 积极列入斯坦福大学露西尔帕卡德儿童医院的移植名单，并在研究入学期间接受了肾移植
排除标准：
- 在斯坦福大学 Lucile Packard 儿童医院以外的中心进行移植
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
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 |
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急性移植物损伤
大体时间：肾移植后六个月内
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由病理学家确定的肾活检证实的急性肾同种异体移植损伤（二元是或否）
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肾移植后六个月内
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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慢性移植物损伤
大体时间：肾移植后六个月
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通过定量纤维化病理学染色（纤维化百分比从 0 到 100%）确定肾活检证实的慢性肾同种异体移植损伤
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肾移植后六个月
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肾功能
大体时间：肾移植后六个月内
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通过 Schwartz 方程计算的肾小球滤过率 (mL/min/1.73
米^2)
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肾移植后六个月内
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蛋白尿
大体时间：肾移植后六个月内
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尿蛋白与肌酐比值高于 0.2 mg/mg 肌酐
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肾移植后六个月内
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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。
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
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- Clark MA, Tallant EA, Diz DI. Downregulation of the AT1A receptor by pharmacologic concentrations of Angiotensin-(1-7). J Cardiovasc Pharmacol. 2001 Apr;37(4):437-48. doi: 10.1097/00005344-200104000-00011.
- Brosnihan KB, Neves LA, Joyner J, Averill DB, Chappell MC, Sarao R, Penninger J, Ferrario CM. Enhanced renal immunocytochemical expression of ANG-(1-7) and ACE2 during pregnancy. Hypertension. 2003 Oct;42(4):749-53. doi: 10.1161/01.HYP.0000085220.53285.11. Epub 2003 Jul 21.
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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)
2014年7月16日
初级完成 (实际的)
2016年1月20日
研究完成 (实际的)
2017年4月26日
研究注册日期
首次提交
2017年10月18日
首先提交符合 QC 标准的
2017年10月18日
首次发布 (实际的)
2017年10月23日
研究记录更新
最后更新发布 (实际的)
2017年11月8日
上次提交的符合 QC 标准的更新
2017年11月6日
最后验证
2017年10月1日
更多信息
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.
肾移植的临床试验
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Hippocration General HospitalReCor Medical, Inc.招聘中