[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631814":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":10,"centralContacts":38,"locations":10,"responsibleParty":48,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":70,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":10},{"fullName":5,"class":6},"Assiut University","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"LN group",null,"1. Adult patients (≥ 18 and \\> 60 years) of either sex.\n2. Fulfill the 2019 EULAR\u002FACR Classification Criteria for Systemic Lupus Erythematosus (SLE) \\[11\\].\n3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g\u002F24h, active urinary sediment, unexplained rise in serum creatinine).\n4. Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) 2018 classification.\n5. 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.\n6. Provision of written informed consent.",[13,14,15],"Other: renal biopsy","Diagnostic Test: serum anti-alpha-actinin antibodies","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",{"label":17,"type":10,"description":18,"interventionNames":19},"SLE without nephritis","Patients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria \\\u003C 0.3 g\u002F24h, normal serum creatinine).",[14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Healthy controls","Age- and sex-matched healthy individuals with no history of autoimmune disease, normal urinalysis, and negative autoantibodies (ANA, anti-dsDNA).",[14,15],[25,29,34],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"renal biopsy","Renal biopsy specimens will be evaluated by light microscopy and will be pathologically classified according to the 2003 International Society of Nephrology\u002F Renal Pathology Society classification (ISN\u002FRPS 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)",[9],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"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.",[21,9,17],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"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).",[21,9,17],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Essam Mohamed Abdel Aziz, MD","CONTACT","+201009699081","essam.abdelaziz@med.aun.edu.eg",{"name":45,"role":41,"phone":46,"phoneExt":10,"email":47},"Mohammed Abbas Sobh, MD","+201067663269","hamed.msobh@aun.edu.eg",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ahmed Aboelfatouh Tantawy","Principal Investigator","100631814","anti-alpha-actinin-antibodies-and-lupus-nephritis-activity-100631814",false,"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","Inclusion Criteria:\n\n1. Inclusion criteria for LN group:\n\n   1. Adult patients (≥ 18 and \\> 60 years) of either sex.\n   2. Fulfill the 2019 EULAR\u002FACR Classification Criteria for Systemic Lupus Erythematosus (SLE).\n   3. Diagnosis of active lupus nephritis requiring a renal biopsy as per standard clinical indications (e.g., proteinuria ≥ 0.5 g\u002F24h, active urinary sediment, unexplained rise in serum creatinine).\n   4. Availability of an adequate renal biopsy specimen for histopathological evaluation according to the International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) 2018 classification.\n   5. 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.\n   6. Provision of written informed consent.\n\n      b)Inclusion Criteria for Control Groups:\n\n   \u003C!-- -->\n\n   1. SLE without nephritis: Patients meeting SLE criteria without any clinical or laboratory evidence of renal involvement (normal urinalysis, proteinuria \\\u003C 0.3 g\u002F24h, normal serum creatinine).\n   2. Healthy controls: Age- and sex-matched healthy individuals with no history of autoimmune disease, normal urinalysis, and negative autoantibodies (ANA, anti-dsDNA).\n\n      Exclusion Criteria:\n\n      \\-\n\n      Participants will be excluded if ANY of the following criteria apply:\n\n   \u003C!-- -->\n\n   1. Other Kidney Diseases:\n\n      * 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).\n   2. Confounding Clinical Conditions:\n\n      * 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.\n      * Presence of advanced chronic kidney disease (CKD Stage 4 or 5) predating the diagnosis of SLE.\n      * Pregnancy or lactation.\n   3. Confounding Medications:\n\n      * Receipt of high-dose corticosteroids (\\> 20 mg\u002Fday 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).",true,"ALL","18 Years","60 Years",{"count":64,"type":65},96,"ESTIMATED","OBSERVATIONAL","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\u002FRenal Pathology Society (ISN\u002FRPS) classifies LN histologically, with proliferative forms (Classes III\u002FIV) carrying the poorest prognosis.",[69],"Lupus Nephritis","NOT_YET_RECRUITING","2026-03-27",{"date":73,"type":74},"2026-04-01","ACTUAL",{"date":73,"type":65},{"date":77,"type":65},"2027-10-01",{"name":5,"class":6}]