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临床试验/NCT04700631
NCT04700631已完成不适用

Extracellular Vesicles as Biomarkers for Chronic Renal Failure

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2021年1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
143
试验地点
2
主要终点
variation of urinary extracellular vesicle concentration between both groups

研究概览

简要总结

The recent discovery of extracellular vesicles (EV) as a mechanism of intercellular communication has made it possible to develop a new field of health research and could bring new information on the pathological mechanisms of renal diseases. Definition of physiologic and pathologic values of urinary extracellular vesicles (EVu) between healthy subjects and chronic kidney diseases (CKD) patients could be a new tool for follow up of renal diseases. EV are found in all biological fluids including urine, that's why they are increasingly analyzed in renal pathologies. The main objective of this study is to determine the physiological values and the pathological thresholds of EVu.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • subject > 18 years old
  • healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI
  • CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m²

排除标准

  • patients under dialysis protocols
  • renal transplant patients

结局指标

主要结局

variation of urinary extracellular vesicle concentration between both groups

时间窗: one day

variation of urinary extracellular vesicle concentration between both groups : healthy and CRF patients Urinary extracellular vesicle concentrations will be measured as number of extracellular vesicles per mL of urine

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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