Dynamic Changes of Neutrophil Extracellular Traps in Lupus Nephritis and Their Role in Predicting Treatment Response.
| Registry | NCT07721857 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 100 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Lupus Nephritis (LN) |
| Interventions | Serum Neutrophil Extracellular Traps (Diagnostic test) |
| Dates | start 2026-09-01 (estimated), primary completion 2028-08-31 (estimated), completion 2028-10-31 (estimated), first posted 2026-07-23, last updated 2026-07-23 |
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All trials for Lupus Nephritis (LN) All trials of Serum Neutrophil Extracellular Traps
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| lupus nephritis group | Diagnostic Test: Serum Neutrophil Extracellular Traps | 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. | |
| control group | Diagnostic Test: Serum Neutrophil Extracellular Traps | 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). |
Sex: All, ages: 18 Years to 60 Years
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.