Not Yet RecruitingNot Applicable

Anti-alpha-actinin Antibodies and Lupus Nephritis Activity

96 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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).

Exclusion criteria

✕. Other Kidney Diseases:
✕. Confounding Clinical Conditions:
✕. Confounding Medications:

What they're measuring

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

Timeframe: 36 months

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

Timeframe: 36 months

Trial details

NCT IDNCT07505576

SponsorAssiut University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-01

Contact for this trial

Essam Mohamed Abdel Aziz, MD

+201009699081 essam.abdelaziz@med.aun.edu.eg

View on ClinicalTrials.gov More Lupus Nephritis trials