CXCR2 Leucocyte Expression Level as a Predictive Factor of Coronary Artery Calcification Progression in Advanced Chronic Kidney Disease Patients
MACXCALCIF
1 other identifier
interventional
100
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2026
CompletedFirst Posted
Study publicly available on registry
September 10, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2031
September 10, 2026
September 1, 2026
2.8 years
July 23, 2026
September 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
variation from baseline of CXCR2 expression
CXCR2 expression will be quantified by flow cytometry (percentage of CXCR2-positive cells) from blood sample.
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.
at 3 years
Secondary Outcomes (8)
CXCR2 expression and the 1-year progression of the calcium score
at 1 year
Correlation between CXCR1 or CXCR2 expression and calcium score trajectory
1 year
Correlation between CXCR2 expression and the calcium score progression in other vascular territories
at 3 years
Correlation between CXCR1 expression and the calcium score progression in other vascular territories
at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and CKD progression
at 3 years
- +3 more secondary outcomes
Study Arms (1)
CKD patients
EXPERIMENTALInterventions
Thoracic CT will be performed at inclusion, 1 year and 3 years to assess coronary calcification and aortic valve calcification scores and progression.
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.
Eligibility Criteria
You may qualify if:
- age \> 18 years
- CKD defined by eGFR \< 30 mL/min/1,73m²
- signed inform consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU Amiens
Amiens, 80480, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2026
First Posted
September 10, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2031
Last Updated
September 10, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share