NCT07811505

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
59mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

2.8 years

First QC Date

July 23, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

chronic kidney diseasecoronary arteries calcificationsCXCR2 expression

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

EXPERIMENTAL
Other: Thoracic CTBiological: Blood samples

Interventions

Thoracic CT will be performed at inclusion, 1 year and 3 years to assess coronary calcification and aortic valve calcification scores and progression.

CKD patients
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.

CKD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

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

Locations