跳至主要内容
临床试验/NCT04950439
NCT04950439进行中(未招募)不适用

Pyrophosphate: a New Biomarker to Predict Arterial Calcification in Chronic Kidney Disease

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2022年3月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
242
试验地点
2
主要终点
Plasma levels of PPI

研究概览

简要总结

Arterial calcifications start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. In uremic rats, low PPi plasma levels are associated with high calcium content in the aorta and peritoneal administration of PPi blocks this process. People on maintenance dialysis or kidney transplant recipients have low plasma levels of PPi and show high scores of arterial calcification. The purpose is to determine the role of low PPi in the development of arterial calcifications in patients with CKD stage 3 or 4. To that aim, 252 patients with eGFR between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval

排除标准

  • kidney transplantation
  • acute inflammatory disease or active cancer

研究组 & 干预措施

Myocardial CT

Other

The investigator will collect the usual clinical history and data. Risk factors and cardiovascular events are identified. A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them.

干预措施: Collect blood sample (Other)

结局指标

主要结局

Plasma levels of PPI

时间窗: 3 years

To show that low plasma levels of PPi at baseline is associated with a high progression of arterial calcification at three years after adjustment for confounding variables

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)

Loading locations...

相似试验