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Neutrophil Extracellular Traps and Lupus Nephritis

19. juli 2026 opdateret af: Hadeer S. Hassan, Assiut University

Dynamic Changes of Neutrophil Extracellular Traps in Lupus Nephritis and Their Role in Predicting Treatment Response.

Lupus Nephritis is one of the most severe organ manifestations of systemic lupus erythematosus and represents a major cause of morbidity, chronic kidney disease, and long-term mortality. Despite significant advances in immunosuppressive therapies, a substantial proportion of patients fail to achieve sustained renal remission or progress to end-stage renal disease, highlighting the need for improved understanding of disease mechanisms and more reliable biomarkers for disease monitoring and therapeutic response

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In recent years, growing evidence has emphasized the role of innate immune dysregulation in the pathogenesis of lupus nephritis, particularly the involvement of neutrophils and aberrant cell death pathways. Among these mechanisms, neutrophil extracellular traps (NETs) have emerged as key mediators of autoimmune-driven inflammation. NETs are extracellular chromatin networks composed of DNA, histones, and granular proteins released by activated neutrophils during NETosis. Although originally described as antimicrobial defense structures, excessive NET formation and impaired degradation have been strongly implicated in systemic autoimmunity.

In lupus nephritis, NETs contribute to renal injury through multiple mechanisms, including exposure of nuclear autoantigens, amplification of type I interferon signaling, activation of complement pathways, and direct cytotoxic effects on endothelial cells and podocytes. Moreover, impaired NET clearance has been demonstrated in SLE, further promoting persistent immune activation and renal inflammation. Recent studies have also suggested that circulating NETs levels are elevated in patients with renal involvement and may correlate with disease activity and outcomes.

However, most available data are cross-sectional, and limited evidence exists regarding the dynamic changes of NETs in response to therapy. Therefore, evaluating NETs before and after treatment may provide important insights into their role as predictive and prognostic biomarkers and potential therapeutic targets in lupus nephritis.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients fulfilling inclusion criteria at internal medicine department, nephrology and rheumatology units, intermediate care unit, and critical care unit hospitalized patients, and in nephrology and rheumatology outpatient clinics, Assiut University Hospital, Egypt

Beskrivelse

Inclusion criteria for LN group:

  1. Adult patients (≥ 18 and > 60 years) of either sex.
  2. Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE) [11].
  3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine).
  4. Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 classification.
  5. Patients planned to initiate standard induction therapy (e.g., mycophenolate mofetil or cyclophosphamide with corticosteroids).
  6. Provision of written informed consent.

Inclusion Criteria for Control Groups:

1) SLE without nephritis: Patients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria < 0.3 g/24h, normal serum creatinine).

Exclusion Criteria:

  • Participants will be excluded if ANY of the following criteria apply:

    1. Other Kidney Diseases:

      • Presence of, or suspicion of, any other primary or significant secondary kidney disease unrelated to SLE (e.g., diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, significant drug-induced nephrotoxicity, rheumatoid arthritis, positive HBs antigen or HCV antibody).

    2. Confounding Clinical Conditions:

      • Presence of an active or recent major infection (e.g., sepsis, pneumonia, UTI) at the time of enrollment, as infection can significantly alter immune markers.

      • Presence of advanced chronic kidney disease (CKD Stage 4 or 5) predating the diagnosis of SLE.

        3 · Pregnancy or lactation.

    4. Recent use (within the last 3 months) of biologic therapies that may affect neutrophil function or NET formation.

    5. Use of medications known to significantly alter neutrophil activity. 6. History of malignancy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
lupus nephritis group

Inclusion criteria for LN group:

  1. Adult patients (≥ 18 and > 60 years) of either sex.
  2. Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE) [11].
  3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g/24h, active urinary sediment, unexplained rise in serum creatinine).
  4. Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 classification.
  5. Patients planned to initiate standard induction therapy (e.g., mycophenolate mofetil or cyclophosphamide with corticosteroids).
  6. Provision of written informed consent.
Diagnostisk test: Serum Neutrophil Extracellular Traps
Serum sample should be collected into a serum separator tube. After clotting for 2 hours at room temperature or overnight at 4°C, and then centrifuging at 1000 × g for 20 minutes. Assay freshly prepared serum immediately or store samples in aliquot at -20°C or -80°C for later use. Avoid repeated freeze-thaw cycles.
control group

Inclusion Criteria for Control Groups:

1) SLE without nephritis: Patients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria < 0.3 g/24h, normal serum creatinine).
Diagnostisk test: Serum Neutrophil Extracellular Traps
Serum sample should be collected into a serum separator tube. After clotting for 2 hours at room temperature or overnight at 4°C, and then centrifuging at 1000 × g for 20 minutes. Assay freshly prepared serum immediately or store samples in aliquot at -20°C or -80°C for later use. Avoid repeated freeze-thaw cycles.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The primary outcome of the study is the change in circulating neutrophil extracellular traps (NETs) levels, in patients with Lupus Nephritis
Tidsramme: 2 years
The primary outcome of the study is the change in circulating neutrophil extracellular traps (NETs) levels, in patients with Lupus Nephritis. NETs levels will be assessed at baseline (prior to initiation of therapy), and at 6 months following treatment
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assiut University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

31. august 2028

Studieafslutning (Anslået)

31. oktober 2028

Datoer for studieregistrering

Først indsendt

19. juli 2026

Først indsendt, der opfyldte QC-kriterier

19. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DCNETLN

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Lupus nefritis (LN)

Kliniske forsøg med Serum Neutrophil Extracellular Traps

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