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NCT07505576Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
96 (estimated)
First submitted
23 Mar 2026
Start date
1 Apr 2026
Primary completion date
1 Apr 2027
Lead sponsor
Assiut University
Diseases
Lupus (SLE)
NCT number
NCT07505576

What you commit to

  • Study type: Observational
  • Planned participants: 96
  • From 1 Apr 2026 to the primary completion date, 1 Apr 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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.

Other

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  • Participants will be excluded if ANY of the following criteria apply:
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Who the study is looking for

  • 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).

Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.