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临床试验/NCT02951442
NCT02951442已完成不适用

Identification of Markers (Klotho-FGF23 Axis) as Determinant in the Evolution of Arterial Stiffness During the First Year of Renal Transplant

Hopital Foch4 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2011年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Hopital Foch
入组人数
117
试验地点
4
主要终点
Carotid-femoral pulse wave velocity

研究概览

简要总结

The primary objective is to show that the contribution of Klotho by the renal graft is an independent determinant of the evolution of the recipient's central arterial stiffness during the first year of renal transplant. The contribution of Klotho by the graft will be estimated by: its circulating concentrations assay, its urinary excretion assay, and, indirectly, by the circulating concentrations of FGF23. The recipient's central arterial stiffness will be estimated by the measure of the carotid-femoral pulse wave velocity, noninvasive reference method for measuring aortic stiffness in human.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Man or woman 18 to 70 years old
  • Renal transplant
  • Dead donor or alive donor
  • Immunosuppression including a calcineurin inhibitor
  • Written consent

排除标准

  • MultipleTransplant
  • Morbid Obesity (Body Mass Index (BMI)> 40 kg/m2 sc)
  • Cardiac Arrhythmia
  • Lower limbs occlusive arterial disease
  • Impossibility to understand the information form

研究组 & 干预措施

Renal Transplant

Experimental

干预措施: Non invasive Arterial investigations (Procedure)

Renal Transplant

Experimental

干预措施: Biological sample (Biological)

Renal Transplant

Experimental

干预措施: Abdominal tomodensitometry (Procedure)

结局指标

主要结局

Carotid-femoral pulse wave velocity

时间窗: 12 months

次要结局

  • Sectional carotid stiffness(12 months)
  • Carotid intima-media thickness(12 months)
  • Endothelial function(12 months)
  • Arterial calcification(12 months)
  • Pulsed central veinous pressure(12 months)
  • Klotho concentration(1 day)
  • FGF23 concentration(1 day)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (4)

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