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CXCR2 Leucocyte Expression Level as a Predictive Factor of Coronary Artery Calcification Progression in Advanced Chronic Kidney Disease Patients (MACXCALCIF)

3. september 2026 oppdatert av: Centre Hospitalier Universitaire, Amiens
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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
      • Amiens, Frankrike, 80480
        • CHRU Amiens
        • Ta kontakt med:
        • Underetterforsker:
          • Dimitri TITECA-BEAUPORT, MD
        • Underetterforsker:
          • Cédric RENARD, MD
        • Underetterforsker:
          • Thomas BOYER, MD
        • Underetterforsker:
          • Youssef BENNIS, Pr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • age > 18 years
  • CKD defined by eGFR < 30 mL/min/1,73m²
  • signed inform consent

Exclusion Criteria:

  • 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: CKD pasienter
Annen: Thoracic CT
Thoracic CT will be performed at inclusion, 1 year and 3 years to assess coronary calcification and aortic valve calcification scores and progression.
Biologisk: Blood samples
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
variation from baseline of CXCR2 expression
Tidsramme: at 3 years
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
Tidsramme: 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.
at 3 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
CXCR2 expression and the 1-year progression of the calcium score
Tidsramme: at 1 year
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 1 year
Correlation between CXCR1 or CXCR2 expression and calcium score trajectory
Tidsramme: 1 year
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.
1 year
Correlation between CXCR2 expression and the calcium score progression in other vascular territories
Tidsramme: 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.
at 3 years
Correlation between CXCR1 expression and the calcium score progression in other vascular territories
Tidsramme: at 3 years
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.
at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and CKD progression
Tidsramme: at 3 years
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.
at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and the occurrence of cardiovascular complications
Tidsramme: at 3 years
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.
at 3 years
Correlation between a CXCR1- or CXCR2-positive leukocyte phenotype and mortality
Tidsramme: at 3 years
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.
at 3 years
Correlation between leukocyte phenotype and serum indoxyl sulfate concentration
Tidsramme: at 3 years
at 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Hospitalier Universitaire, Amiens

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

1. august 2029

Studiet fullført (Antatt)

1. august 2031

Datoer for studieregistrering

Først innsendt

23. juli 2026

Først innsendt som oppfylte QC-kriteriene

3. september 2026

Først lagt ut (Faktiske)

10. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PI2026_843_0037

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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