Anti-alpha-actinin Antibodies and Lupus Nephritis Activity
Starting soon
Conditions studied: Lupus Nephritis
In brief
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.
Key facts
- Study ID
- NCT07505576
- Run by
- Assiut University
- People needed
- 96
- Starts
- 2026-04-01
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-04-01
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inclusion criteria for LN group:
- 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.
- Renal biopsy performed within 3 months prior to enrollment, and patient has not received induction immunosuppressive therapy (cyclophosphamide, mycophenolate mofetil, or calcineurin inhibitors) in the period between biopsy and enrollment.
- Provision of written informed consent.
- b)Inclusion Criteria for Control Groups:
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- 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).
- Healthy controls: Age- and sex-matched healthy individuals with no history of autoimmune disease, normal urinalysis, and negative autoantibodies (ANA, anti-dsDNA).
You may not qualify if…
- Participants will be excluded if ANY of the following criteria apply:
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- 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.
- Confounding Medications:
- Receipt of high-dose corticosteroids (> 20 mg/day of prednisone or equivalent) or any potent immunosuppressive agent (e.g., cyclophosphamide, mycophenolate mofetil, rituximab) within 4 weeks prior to the renal biopsy and blood sampling).
Full record on ClinicalTrials.gov
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