Chronic Kidney DiseaseMACXCALCIFNCT07811505
CXCR2 Leucocyte Expression Level as a Predictive Factor of Coronary Artery Calcification Progression in Advanced Chronic Kidney Disease Patients
A study testing Thoracic CT and Blood samples in people with Chronic Kidney Disease and Coronary Arteries Calcifications, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Chronic kidney disease (CKD) is associated with the development of coronary arteries calcifications (CAC) and increased cardiovascular mortality. Previously, the investigators demonstrated that interleukin 8 (IL-8) plays a role in the calcification process, and that blockade of its receptor, CXCR2 reduces… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Coronary Arteries Calcifications, CXCR2 Expression
- What is being tested?
- Thoracic CT and Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2026to Aug 2031
- 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
- age > 18 years
- CKD defined by eGFR < 30 mL/min/1,73m²
- signed inform consent
Who cannot join
- patients on dialysis,
- kidney transplant recipients,
- current or recent (within 30 days) infection,
- inflammatory diseases,
- active cancer treatment,
- use of immunosuppressive agents,
- presence of coronary stents or aortic valve protheses,
- inability to provide informed consent.
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
CHRU Amiens
Amiens, 80480
Quentin de berny, MD, 33+3 22 45 58 62, deberny.quentin@chu-amiens.fr
Dimitri TITECA-BEAUPORT, MD
About this study
Chronic kidney disease (CKD) is associated with the development of coronary arteries calcifications (CAC) and increased cardiovascular mortality. Previously, the investigators demonstrated that interleukin 8 (IL-8) plays a role in the calcification process, and that blockade of its receptor, CXCR2 reduces cardiovascular calcifications. The investigators hypothesize that leucocytes expressing CXCR2 may contribute to the development and progression of CAC in CKD patients. Identifying CKD patients with a high calcification phenotype and therapeutic targets to prevent cardiovascular calcifications is essential. Advanced CKD patients (stages IV and V) will undergo analysis of CXCR2 expression from neutrophils and monocytes at inclusion by flow cytometry, followed by non-contrast thoracic CT scans at inclusion, 1 year and 3 years to assess calcification scores and progression. Patients will have a pre-inclusion visit for research information and consent. If consent is given, three protocol visits (inclusion, 1 year, 3 years) including clinical exam, laboratory tests and CT evaluations will be performed.
- Being tested
- Thoracic CT, Blood samples
- Keywords
- chronic kidney disease, coronary arteries calcifications, CXCR2 expression
- 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.
Thoracic CTOther
Thoracic CT will be performed at inclusion, 1 year and 3 years to assess coronary calcification and aortic valve calcification scores and progression.
Blood samplesBiological
Blood samples will be collected at inclusion, 1 year and 3 years to measure CXCR1 and CXR2 expression on neutrophils and monocytes by flow cytometry.
| Study group | Role | What they receive |
|---|---|---|
| CKD patients | Experimental | Not described Receives: Other: Thoracic CT; Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation from baseline of CXCR2 expression
CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
Measured: at 3 years
Correlation between CXCR2 expression and calcium score
The coronary calcification score will be determined by Agatston method. CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
Measured: at 3 years
Secondary outcomes (8)
CXCR2 expression and the 1-year progression of the calcium score
The coronary calcification score will be determined by Agatston method. CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
Measured: at 1 year
Correlation between CXCR1 or CXCR2 expression and calcium score trajectory
The coronary calcification score will be determined by Agatston method. CXCR2 expression and CXCR1 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells and percentage of CXCR1 positive cells) from blood sample.
Measured: 1 year
Correlation between CXCR2 expression and the calcium score progression in other vascular territories
The coronary calcification score will be determined by Agatston method. CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
Measured: at 3 years
Correlation between CXCR1 expression and the calcium score progression in other vascular territories
The coronary calcification score will be determined by Agatston method. CXCR1 expression will be quantified by flow cytometry (percentage of CXCR1-positive cells) from blood sample.
Measured: at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and CKD progression
The coronary calcification score will be determined by Agatston method. CXCR2 expression and CXCR1 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells and percentage of CXCR1 positive cells) from blood sample.
Measured: at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and the occurrence of cardiovascular complications
CXCR2 expression and CXCR1 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells and percentage of CXCR1 positive cells) from blood sample.
Measured: at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and mortality
CXCR2 expression and CXCR1 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells and percentage of CXCR1 positive cells) from blood sample.
Measured: at 3 years
Correlation between leukocyte phenotype and serum indoxyl sulfate concentration
Measured: at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811505
- Sponsor's protocol ID
- PI2026_843_0037
- Acronym
- MACXCALCIF
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CXCR2 Leucocyte Expression Level as a Predictive Factor of Coronary Artery Calcification Progression in Advanced Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT07811505
- Acronym / sponsor ID
- MACXCALCIF / PI2026_843_0037
- Keywords
- chronic kidney disease, coronary arteries calcifications, CXCR2 expression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 10 Sep 2026 (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.
Chronic kidney disease (CKD) is associated with the development of coronary arteries calcifications (CAC) and increased cardiovascular mortality. Previously, the investigators demonstrated that interleukin 8 (IL-8) plays a role in the calcification process, and that blockade of its receptor, CXCR2 reduces cardiovascular calcifications. The investigators hypothesize that leucocytes expressing CXCR2 may contribute to the development and progression of CAC in CKD patients. Identifying CKD patients with a high calcification phenotype and therapeutic targets to prevent cardiovascular calcifications is essential. Advanced CKD patients (stages IV and V) will undergo analysis of CXCR2 expression from neutrophils and monocytes at inclusion by flow cytometry, followed by non-contrast thoracic CT scans at inclusion, 1 year and 3 years to assess calcification scores and progression. Patients will have a pre-inclusion visit for research information and consent. If consent is given, three protocol visits (inclusion, 1 year, 3 years) including clinical exam, laboratory tests and CT evaluations will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD patients | Experimental | Other: Thoracic CT, Biological: Blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years
- CKD defined by eGFR < 30 mL/min/1,73m²
- signed inform consent
Key exclusion criteria (8 listed)
- patients on dialysis,
- kidney transplant recipients,
- current or recent (within 30 days) infection,
- inflammatory diseases,
- active cancer treatment,
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 |
|---|---|---|
| Thoracic CTThoracic CT will be performed at inclusion, 1 year and 3 years to assess coronary calcification and aortic valve calcification scores and progression. | Other | CKD patients |
| Blood samplesBlood samples will be collected at inclusion, 1 year and 3 years to measure CXCR1 and CXR2 expression on neutrophils and monocytes by flow cytometry. | Biological | CKD patients |
Primary outcome
variation from baseline of CXCR2 expression
Time frame: at 3 years
CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
Correlation between CXCR2 expression and calcium score
Time frame: at 3 years
The coronary calcification score will be determined by Agatston method. CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
8 secondary outcomes
CXCR2 expression and the 1-year progression of the calcium score
Time frame: at 1 year
Correlation between CXCR1 or CXCR2 expression and calcium score trajectory
Time frame: 1 year
Correlation between CXCR2 expression and the calcium score progression in other vascular territories
Time frame: at 3 years
Correlation between CXCR1 expression and the calcium score progression in other vascular territories
Time frame: at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and CKD progression
Time frame: at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and the occurrence of cardiovascular complications
Time frame: at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and mortality
Time frame: at 3 years
Correlation between leukocyte phenotype and serum indoxyl sulfate concentration
Time frame: at 3 years
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 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Chronic Kidney Disease
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 Thoracic CT and Blood samples in people with Chronic Kidney Disease and Coronary Arteries Calcifications, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 10 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?
Contact Quentin DE BERNY, MD (33+3 22 45 58 62, deberny.quentin@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation from baseline of CXCR2 expression (time frame: at 3 years). The study lists 2 primary outcomes in all. 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 10 Sep 2026; AzTrials last refreshed its copy on 1 Nov 2026.