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

March 7, 2024 updated by: Centre Hospitalier Universitaire de Nice

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Alpes-Mritimes
      • Nice, Alpes-Mritimes, France, 06300
        • CHU Nice - Hôpital de l'Archet 2
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CKD group
Patient with chronic kidney disease
Other: PPI and T50 dosing
Sampling for PPI determination and T50 in blood and urine.
Experimental: Dialysis group
Dialysis patients (hemodialysis or peritoneal dialysis)
Other: PPI and T50 dosing
Sampling for PPI determination and T50 in blood and urine.
Experimental: kidney transplant group
Kidney transplant patients
Other: PPI and T50 dosing
Sampling for PPI determination and T50 in blood and urine.
Active Comparator: Control group
Control group of patients with normal renal function
Other: PPI and T50 dosing
Sampling for PPI determination and T50 in blood and urine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months
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.
18 months
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.
18 months
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-AOI-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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