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临床试验/NCT06300788
NCT06300788招募中不适用

Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease - PPi-DIA

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Plasma pyrophosphate concentration [PPi]pl in children with CKD

研究概览

简要总结

The investigator aim to identify the role of inorganic pyrophosphate and other anti-calcifying molecules in vascular disease in children with chronic kidney disease, with a view to developing therapeutic approaches aimed at limiting the onset of vasculopathy.

详细描述

The study of pro- and anti-calcifying molecules in children with chronic kidney disease will be carried out using dosages made on serum in comparison with the dosage of these same molecules in control children matched according to age and sex. without chronic kidney disease. An evaluation of vascular function by clinical (auscultation, palpation) and ultrasound techniques (measurement of intima-media thickness and measurement of pulse wave velocity) will also be carried out in children with chronic kidney disease and compared to norms of children without chronic kidney disease. These evaluations aim to improve understanding of the pathophysiology of vascular calcification and thus open up therapeutic perspectives in these children.

研究设计

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

入排标准

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

入选标准

  • All groups :
  • Minor patients (<18 years)
  • Patients of both sexes
  • Informed patients and parents who have signed the informed consent form
  • Patients affiliated to social security
  • Control group :
  • - Patients with no particular pathology undergoing surgery and receiving a preoperative check-up
  • CKD groups :
  • Patients on dialysis for more than 3 months, regardless of technique
  • Kidney transplant patients
  • Patients with CKD, whatever the cause

排除标准

  • Progressive cancer or kidney disease
  • Treatments that may modify PPi concentration (e.g. bisphosphonates)

研究组 & 干预措施

CKD group

Experimental

Patient with chronic kidney disease

干预措施: PPI and T50 dosing (Other)

Dialysis group

Experimental

Dialysis patients (hemodialysis or peritoneal dialysis)

干预措施: PPI and T50 dosing (Other)

kidney transplant group

Experimental

Kidney transplant patients

干预措施: PPI and T50 dosing (Other)

Control group

Active Comparator

Control group of patients with normal renal function

干预措施: PPI and T50 dosing (Other)

结局指标

主要结局

Plasma pyrophosphate concentration [PPi]pl in children with CKD

时间窗: 18 months

Compare plasma pyrophosphate concentration \[PPi\]pl between children with CKD (dialysis group and non-dialysis, non-transplant group) and \[PPi\]pl of children with normal renal function. Plasma PPi concentration during fasting sampling; (μmol/L) by a proprietary assay developed at LP2M. We will match the 3 MRC groups with their respective control groups according to age, sex and pubertal stage.

次要结局

  • Markers of vascular damage in CKD(18 months)
  • Markers of phosphocalcic metabolism(18 months)
  • Plasma pyrophosphate [PPi]pl concentration in children with renal transplantation(18 months)
  • Urinary PPi concentration(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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