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临床试验/NCT05122845
NCT05122845已完成不适用

Constitutive Study of a Serum Bank and Plasma Bank of Healthy Subjects Comparators to Dialysis Subjects (SPSSCD)

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年4月12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
25
试验地点
2
主要终点
Number of participant with a serum and plasma bank creation

研究概览

简要总结

To be able to evaluate the predictive value of glycosylated ferritin as a predictive marker of hepatic iron stock in dialysis patients, we need to validate these results with a cohort of healthy volunteers.

详细描述

This biological collection will include a sample of 2 dry tubes and 2 EDTA tubes. A haematological assessment (CBC, platelets, reticulocytes, Chr (hemoglobin content of reticulocytes), TP-INR, AST, ALT, GGT), measurement of biological markers of iron metabolism (ferritin, serum iron, CRP, transferrin, soluble receptors transferrin, transferrin saturation coefficient) as well as a creatinine assay to validate the normality of renal function in healthy volunteers (GFR established from the MDRD formula), a complete ionogram and a phosphocalcic balance being given the interactions in the dialysis patient (but also in normal subjects) between iron metabolism and phosphocalcic metabolism (calcemia, phosphoremia, PTH, 25OHD3, 1,25OH2D3) will be performed.

We will also study the links between iron overload in dialysis patients and the modulation of the synthesis of parathyroid hormone (intact PTH), FGF23, alpha Klotho and sclerostin.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

  • Informed consent
  • Age over 18 years old
  • Healthy volunteers
  • Having given their informed consent in writing
  • Absence of current pathology
  • No current treatment (except contraception)

排除标准

  • Refusal of consent or absence of signature
  • Minor, subject protected by law, (guardianship or curatorship, administrative protection measure)
  • Pregnant woman, parturient
  • Subject suffering from a condition liable to modify his blood parameters

结局指标

主要结局

Number of participant with a serum and plasma bank creation

时间窗: one day

it is only a serum and plasma bank constitution

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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