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Clinical Trials/NCT06300788
NCT06300788
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country60 target enrollmentStarted: May 27, 2024Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Plasma pyrophosphate concentration [PPi]pl in children with CKD

Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
0 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Plasma pyrophosphate concentration [PPi]pl in children with CKD

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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