Chronic Kidney DiseasesPredicalNCT04950439
Pyrophosphate and Arterial Calcification in Chronic Kidney Disease
A study testing Collect blood sample in people with Chronic Kidney Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Arterial calcifications start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Collect blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2022to 14 Mar 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval
Who cannot join
- kidney transplantation
- acute inflammatory disease or active cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pyrophosphate: a New Biomarker to Predict Arterial Calcification in Chronic Kidney Disease
Arterial calcifications start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. In uremic rats, low PPi plasma levels are associated with high calcium content in the aorta and peritoneal administration of PPi blocks this process. People on maintenance dialysis or kidney transplant recipients have low plasma levels of PPi and show high scores of arterial calcification. The purpose is to determine the role of low PPi in the development of arterial calcifications in patients with CKD stage 3 or 4. To that aim, 252 patients with eGFR between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Collect blood sample
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect blood sampleOther
A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them.
| Study group | Role | What they receive |
|---|---|---|
| Myocardial CT | Other | The investigator will collect the usual clinical history and data. Risk factors and cardiovascular events are identified. A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them. Receives: Other: Collect blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of PPI
To show that low plasma levels of PPi at baseline is associated with a high progression of arterial calcification at three years after adjustment for confounding variables
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start14 Mar 2022
- Primary completion14 Mar 2028 (estimated)
- Study completion14 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Favre Guillaume, PhD, Principal investigator, CHU de Nice, Service de Néphrologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950439
- Sponsor's protocol ID
- 19-API-02
- Acronym
- Predical
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pyrophosphate: a New Biomarker to Predict Arterial Calcification in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04950439
- Acronym / sponsor ID
- Predical / 19-API-02
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 14 Mar 2028 (estimated)
- Study completion
- 14 Mar 2029 (estimated)
- First posted
- 6 Jul 2021 (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.
Arterial calcifications start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. In uremic rats, low PPi plasma levels are associated with high calcium content in the aorta and peritoneal administration of PPi blocks this process. People on maintenance dialysis or kidney transplant recipients have low plasma levels of PPi and show high scores of arterial calcification. The purpose is to determine the role of low PPi in the development of arterial calcifications in patients with CKD stage 3 or 4. To that aim, 252 patients with eGFR between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial CT | Other | Other: Collect blood sampleThe investigator will collect the usual clinical history and data. Risk factors and cardiovascular events are identified. A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- eGFR between 59 et 20 ml/min/1,73 m2 twice at three month interval
Key exclusion criteria (2 listed)
- kidney transplantation
- acute inflammatory disease or active cancer
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 |
|---|---|---|
| Collect blood sampleA blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them. | Other | Myocardial CT |
Primary outcome
Plasma levels of PPI
Time frame: 3 years
To show that low plasma levels of PPi at baseline is associated with a high progression of arterial calcification at three years after adjustment for confounding variables
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 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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. This study is not recruiting at the moment.
Favre Guillaume, PhD principal investigator
CHU de Nice, Service de Néphrologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collect blood sample in people with Chronic Kidney Diseases, 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 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of PPI (time frame: 3 years). 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 29 Sep 2026.