Neutrophil Extracellular Traps and Lupus Nephritis

ConditionLupus Nephritis (LN)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-60

SponsorAssiut University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: lupus nephritis group1 intervention

Group B: control group1 intervention

Trial outcomes

Primary outcomes

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

Time frame

2 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

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