Anti-alpha-actinin Antibodies and Lupus Nephritis Activity

ConditionLupus Nephritis

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-60

SponsorAssiut University

About this trial

Lupus nephritis (LN) develops in 30-60% of systemic lupus erythematosus (SLE) patients and remains a leading cause of morbidity, with 10-30% progressing to end-stage renal disease within 15 years. The International Society of Nephrology/Renal Pathology Society (ISN/RPS) classifies LN histologically, with proliferative forms (Classes III/IV) carrying the poorest prognosis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult patients (≥ 18 and > 60 years) of either sex.

Fulfill the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus (SLE).

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.

Pregnancy or lactation.

Trial population

1. 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). 2. 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

renal biopsy
Other intervention
Renal biopsy specimens will be evaluated by light microscopy and will be pathologically classified according to the 2003 International Society of Nephrology/ Renal Pathology Society classification (ISN/RPS Classification) as minimal mesangial (class I), mesangial proliferative LN (class II), focal LN (class III), diffuse LN (class IV), membranous LN (class V) and advanced sclerosis (class VI)
serum anti-alpha-actinin antibodies
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.
CBC, serum creatinine and urea, estimated GFR, ESR, CRP, urine analysis, ANA, anti dsDNA, C3 & C4, serum albumin, 24-hrs urinary protein, and U. ACR
Diagnostic test
Laboratory tests including, complete blood count (CBC, serum creatinine and urea and estimated GFR according to CKD-EPI and KDIGO;2024, urine analysis, C-reactive protein (CRP), Erythrocyte Sedimination Rate (ESR), anti-nuclear antibodies (ANA), serum albumin, serum complement (C3 and C4) ,anti-double stranded deoxyribonucleic acid (anti-dsDNA), 24-hrs urinary protein and urinary albumin:creatinine ratio (U. ACR).

Treatment groups

96 Participants

are divided into 3 treatment groups

Group A: LN group3 interventions

Group B: SLE without nephritis2 interventions

Group C: Healthy controls2 interventions

Trial outcomes

Primary outcomes

evaluate associations between anti-alpha-actinin antibody levels and specific histological features of active LN

To evaluate associations between anti-alpha-actinin antibody levels and specific histological features of active LN, including endocapillary hypercellularity, fibrinoid necrosis, and cellular crescents.

Time frame

36 months

measure serum anti-alpha-actinin antibody levels in patients with biopsy-proven active lupus nephritis

To measure serum anti-alpha-actinin antibody levels in patients with biopsy-proven active lupus nephritis and assess their correlation with the NIH histopathological activity index.

Time frame

36 months

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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