Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, ControlPPi-DIANCT06300788
Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease
A study testing PPI and T50 dosing in people with Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, Control, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, Control
- What is being tested?
- PPI and T50 dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2024to 27 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 :
Show all 11Show fewer
- 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
Who cannot join
- Progressive cancer or kidney disease
- Treatments that may modify PPi concentration (e.g. bisphosphonates)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Maritimes, 06200
Julie BERNARDOR, 04.92.03.63.65 ext. +33, bernardor.j@chu-nice.fr
About this study
Official title: 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.
Read the 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.
- Being tested
- PPI and T50 dosing
- Keywords
- Pyrophosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI and T50 dosingOther
Sampling for PPI determination and T50 in blood and urine.
| Study group | Role | What they receive |
|---|---|---|
| CKD group | Experimental | Patient with chronic kidney disease Receives: Other: PPI and T50 dosing |
| Dialysis group | Experimental | Dialysis patients (hemodialysis or peritoneal dialysis) Receives: Other: PPI and T50 dosing |
| kidney transplant group | Experimental | Kidney transplant patients Receives: Other: PPI and T50 dosing |
| Control group | Active comparator | Control group of patients with normal renal function Receives: Other: PPI and T50 dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pyrophosphate concentration [PPi]pl in children with CKD
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.
Measured: 18 months
Secondary outcomes (4)
Plasma pyrophosphate [PPi]pl concentration in children with renal transplantation
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.
Measured: 18 months
Markers of phosphocalcic metabolism
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.
Measured: 18 months
Urinary PPi concentration
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.
Measured: 18 months
Markers of vascular damage in CKD
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start27 May 2024
- Primary completion27 Nov 2027 (estimated)
- Study completion27 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, ControlStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300788
- Sponsor's protocol ID
- 23-AOI-02
- Acronym
- PPi-DIA
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease - PPi-DIA
- ClinicalTrials.gov ID
- NCT06300788
- Acronym / sponsor ID
- PPi-DIA / 23-AOI-02
- Keywords
- Pyrophosphate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 27 Nov 2027 (estimated)
- Study completion
- 27 Nov 2027 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD group | Experimental | Other: PPI and T50 dosingPatient with chronic kidney disease |
| Dialysis group | Experimental | Other: PPI and T50 dosingDialysis patients (hemodialysis or peritoneal dialysis) |
| kidney transplant group | Experimental | Other: PPI and T50 dosingKidney transplant patients |
| Control group | Active comparator | Other: PPI and T50 dosingControl group of patients with normal renal function |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Minor patients (<18 years)
- Patients of both sexes
- Informed patients and parents who have signed the informed consent form
- Patients affiliated to social security
- Patients with no particular pathology undergoing surgery and receiving a preoperative check-up
Key exclusion criteria (2 listed)
- Progressive cancer or kidney disease
- Treatments that may modify PPi concentration (e.g. bisphosphonates)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI and T50 dosingSampling for PPI determination and T50 in blood and urine. | Other | CKD group, Control group, Dialysis group, kidney transplant group |
Primary outcome
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.
4 secondary outcomes
Plasma pyrophosphate [PPi]pl concentration in children with renal transplantation
Time frame: 18 months
Markers of phosphocalcic metabolism
Time frame: 18 months
Urinary PPi concentration
Time frame: 18 months
Markers of vascular damage in CKD
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI and T50 dosing in people with Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, Control, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie BERNARDOR (04.92.03.63.65 ext. +33, bernardor.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma pyrophosphate concentration [PPi]pl in children with CKD (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.