Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease

NCT ID: NCT06300788

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-27

Study Completion Date

2026-11-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, Control

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CKD group

Patient with chronic kidney disease

Group Type EXPERIMENTAL

PPI and T50 dosing

Intervention Type OTHER

Sampling for PPI determination and T50 in blood and urine.

Dialysis group

Dialysis patients (hemodialysis or peritoneal dialysis)

Group Type EXPERIMENTAL

PPI and T50 dosing

Intervention Type OTHER

Sampling for PPI determination and T50 in blood and urine.

kidney transplant group

Kidney transplant patients

Group Type EXPERIMENTAL

PPI and T50 dosing

Intervention Type OTHER

Sampling for PPI determination and T50 in blood and urine.

Control group

Control group of patients with normal renal function

Group Type ACTIVE_COMPARATOR

PPI and T50 dosing

Intervention Type OTHER

Sampling for PPI determination and T50 in blood and urine.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PPI and T50 dosing

Sampling for PPI determination and T50 in blood and urine.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Maritimes, France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julie BERNARDOR

Role: CONTACT

04.92.03.63.65 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julie BERNARDOR

Role: primary

04.92.03.63.65 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-AOI-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Renal Impairment Study for PF-06651600
NCT04037865 TERMINATED PHASE1
Apixaban in Hemodialysis
NCT02672709 COMPLETED PHASE4