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临床试验/NCT03274921
NCT03274921已完成不适用

Identification of BIOmarkers for Detection and Understanding of Cardiovascular Complications in Chronic Kidney Disease

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Plasma accumulation of new retention solutes

研究概览

简要总结

Identification of new retention solutes associated with cardiovascular (CV) toxicity in Chronic Kidney Disease (CKD) patients will help to better understand the pathophysiological mechanisms at stake and to prevent CKD-associated mortality and morbidity. For a molecule to be defined as a toxic retention solute, plasma accumulation in the course of CKD has to be demonstrated but also proof needs to be made that plasma accumulation during CKD is indeed associated with an increased risk of CV complications. Moreover, precise determination of the plasma concentration has to be performed in order to later study in vitro and in vivo the toxic mechanisms involved. Based on previous results of plasma proteome analysis using mass spectrometry, a previous study has selected 10 promising protein candidates. These proteins accumulated in the plasma of patients during CKD progression and are known to be associated with CV events in non-CKD patients. The objective of the present study is now to 1) evaluate the association of the plasma accumulation of the 10 retention solutes with CV complications in CKD patients and 2) determine their plasma concentration using ELISA. One hundred and seventy six patients with advanced CKD will be included and divided in 2 groups: 44 patients with history of CV complications in the past 4 years and 132 patients free of any CV complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient with stage 4 or 5 CKD.

排除标准

  • patient with stage 1, 2 or 3 CKD
  • patient with solid tumor
  • patient with malignant blood disease
  • patient with acute kidney disease in the past 3 months
  • patient with acute glomerulonephritis in the past 6 months.

结局指标

主要结局

Plasma accumulation of new retention solutes

时间窗: Day 0

evaluate the plasma accumulation of the 10 retention solutes using mass spectrometry

次要结局

  • determine their plasma concentration(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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