Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease

Not Applicable

Recruiting

• Conditions: Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, Control
• Interventions: Other: PPI and T50 dosing

• Registration Number: NCT06300788
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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 Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-08
• Study Start: 2024-05-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-11-27
• Study Completion: 2025-11-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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
• Patients with CKD, whatever the cause

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dialysis group	PPI and T50 dosing	Dialysis patients (hemodialysis or peritoneal dialysis)
Control group	PPI and T50 dosing	Control group of patients with normal renal function
CKD group	PPI and T50 dosing	Patient with chronic kidney disease
kidney transplant group	PPI and T50 dosing	Kidney transplant patients

Primary Outcome Measures

Name	Time	Method
Plasma pyrophosphate concentration [PPi]pl in children with CKD	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 Outcome Measures

Name	Time	Method
Markers of vascular damage in CKD	18 months	To look for an association between blood and urine Ppi concentrations and markers of vascular damage in MRC in each of the 3 MRC groups.; The following markers of vascular damage in CKD will be studied: * Measurement of aortic stiffness by ultrasound aortic pulse wave velocity; * Measurement of carotid intima-media thickness by ultrasound
Markers of phosphocalcic metabolism	18 months	To investigate an association between plasma PPi concentration and markers of phosphocalcium metabolism in patients in the 3 MRC groups: dialysis, transplant and non-dialysis/non-transplant).; The T50 (Serum protection against vascular calcification) marker of phosphocalcium metabolism will be studied.
Plasma pyrophosphate [PPi]pl concentration in children with renal transplantation	18 months	To compare the plasma pyrophosphate \[PPi\]pl concentration of children with renal transplantation with that of children with dialyzed CKD and children with normal renal function.; Plasma PPi concentration during fasting sampling; (μmol/L) by a patented assay developed at LP2M.
Urinary PPi concentration	18 months	To search for an association between urinary Ppi concentration and markers of phosphocalcium metabolism in patients in the 3 MRC groups: dialysis, transplant and non-dialysis/non-transplant).; Urinary PPi concentration will be measured by a patented assay developed at LP2M.

Trial Locations

Locations (1)

CHU Nice - Hôpital de l'Archet 2; 🇫🇷 Nice, Alpes-Maritimes, France