Neutrophil Extracellular Traps and Lupus Nephritis

NCT07721857 | Not Yet Recruiting

• 1 other identifier: DCNETLN
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Lupus Nephritis (LN)

Outcome Measures

Primary Outcomes (1)

• The primary outcome of the study is the change in circulating neutrophil extracellular traps (NETs) levels, in patients with Lupus Nephritis

  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

Study Arms (2)

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.

Diagnostic Test: Serum Neutrophil Extracellular Traps

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).

Diagnostic Test: Serum Neutrophil Extracellular Traps

Interventions

Serum Neutrophil Extracellular Traps DIAGNOSTIC_TEST

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; lupus nephritis group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Adult patients (≥ 18 and \> 60 years) of either sex.
• Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE) \[11\].
• 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).
• Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2018 classification.
• Patients planned to initiate standard induction therapy (e.g., mycophenolate mofetil or cyclophosphamide with corticosteroids).
• Provision of written informed consent.
• \) 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).

You may not qualify if:

• Participants will be excluded if ANY of the following criteria apply:
• 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).
• 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.
• · Pregnancy or lactation.
• \. Recent use (within the last 3 months) of biologic therapies that may affect neutrophil function or NET formation.
• \. Use of medications known to significantly alter neutrophil activity. 6. History of malignancy.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Chen X, Gao D, Wang M, Wang L, Hu H, Wen C, Tang Y. Neutrophil Extracellular Traps in Systemic Lupus Erythematosus: Pathogenic Mechanisms, Crosstalk with Oxidative Stress, and Antioxidant Therapeutic Potential. Antioxidants (Basel). 2025 Dec 23;15(1):25. doi: 10.3390/antiox15010025.

  PMID: 41596085 BACKGROUND

• Yu Y, Su K. Neutrophil Extracellular Traps and Systemic Lupus Erythematosus. J Clin Cell Immunol. 2013 Apr;4:139. doi: 10.4172/2155-9899.1000139.

  PMID: 24244889 BACKGROUND

• Carmona-Rivera C, Zhao W, Yalavarthi S, Kaplan MJ. Neutrophil extracellular traps induce endothelial dysfunction in systemic lupus erythematosus through the activation of matrix metalloproteinase-2. Ann Rheum Dis. 2015 Jul;74(7):1417-24. doi: 10.1136/annrheumdis-2013-204837. Epub 2014 Feb 25.

  PMID: 24570026 BACKGROUND

• Hakkim A, Furnrohr BG, Amann K, Laube B, Abed UA, Brinkmann V, Herrmann M, Voll RE, Zychlinsky A. Impairment of neutrophil extracellular trap degradation is associated with lupus nephritis. Proc Natl Acad Sci U S A. 2010 May 25;107(21):9813-8. doi: 10.1073/pnas.0909927107. Epub 2010 May 3.

  PMID: 20439745 BACKGROUND

• Liu L, de Leeuw K, van Goor H, Doornbos-van der Meer B, Arends S, Westra J. Neutrophil extracellular traps and oxidative stress in systemic lupus erythematosus patients with and without renal involvement. Arthritis Res Ther. 2024 Dec 19;26(1):220. doi: 10.1186/s13075-024-03454-y.

  PMID: 39702549 BACKGROUND

• Gupta S, Kaplan MJ. The role of neutrophils and NETosis in autoimmune and renal diseases. Nat Rev Nephrol. 2016 Jul;12(7):402-13. doi: 10.1038/nrneph.2016.71. Epub 2016 May 31.

  PMID: 27241241 BACKGROUND

• Mok CC, Teng YKO, Saxena R, Tanaka Y. Treatment of lupus nephritis: consensus, evidence and perspectives. Nat Rev Rheumatol. 2023 Apr;19(4):227-238. doi: 10.1038/s41584-023-00925-5. Epub 2023 Mar 2.

  PMID: 36864291 BACKGROUND

• Lichtnekert J, Anders HJ. Lupus nephritis-related chronic kidney disease. Nat Rev Rheumatol. 2024 Nov;20(11):699-711. doi: 10.1038/s41584-024-01158-w. Epub 2024 Sep 24.

  PMID: 39317803 BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Salwa Salah elgendi, MD

CONTACT

+0201005766155; salwaelgendi@aun.edu.eg

Mai Mostafa Mohamed, MD

CONTACT

+0201223971678; mai_heamatology@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07