CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Maritimes, 06200, France
Location status: Recruiting
Recruiting
NCT Number: NCT06300788
Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
0 year–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
PPI and T50 dosing
OtherSampling for PPI determination and T50 in blood and urine.
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
-
Plasma pyrophosphate [PPi]pl concentration in children with renal transplantation
Time frame: 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.
-
Markers of phosphocalcic metabolism
Time frame: 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.
-
Urinary PPi concentration
Time frame: 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.
-
Markers of vascular damage in CKD
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire de Nice
Other
Registry information
Official study title
Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease - PPi-DIA
Acronym: PPi-DIA
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 8, 2024
- Registry last updated
- Jul 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.