NCT07505576

Anti-alpha-actinin Antibodies and Lupus Nephritis Activity

Serum Anti-alpha-actinin Antibodies as an Early Biomarker for Histological Activity in Lupus Nephritis and Its Correlation With Other Conventional Serological Markers

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 96 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Current monitoring tools have significant limitations. Conventional markers (anti-dsDNA, C3/C4) correlate imperfectly with renal activity, as 20-30% of active LN patients have normal anti-dsDNA levels. Renal biopsy remains the gold standard for assessing histological activity through the NIH activity index, but is invasive and cannot be repeated frequently. Anti-alpha-actinin-4 antibodies have emerged as promising biomarkers. Alpha-actinin-4 is a podocyte cytoskeletal protein critical for glomerular filtration barrier integrity. A subset of anti-dsDNA antibodies cross-reacts with alpha-actinin, directly linking systemic autoimmunity to renal injury. These antibodies induce podocyte damage, complement activation, and correlate with proteinuria and histological activity. However, comprehensive evaluation of their correlation with detailed histopathological activity indices remains limited, particularly in understudied populations. This study aims to assess the relationship between serum anti-alpha-actinin antibodies and the renal histopathological activity index in LN patients, comparing their performance with conventional serological markers.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
OTHER	renal biopsy	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)
DIAGNOSTIC_TEST	serum anti-alpha-actinin antibodies	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.
DIAGNOSTIC_TEST	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	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).

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-10-01
• First posted: 2026-04-01
• Last updated: 2026-04-01