Association Between Neuropathy and Some Autoantibodies in Systemic Lupus Erythematosus (SLE) Patients

NCT06610422 | Not Yet Recruiting

• 1 other identifier: Nephropathy and systemic lupus
• Study Type: observational
• Target: 159
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Frequency of peripheral neuropathy associated with lupus nephritis
2. 2.Sensitivity and specificity of some biomarkers used in diagnosis and follow up of SLE with lupus nephritis and peripheral neuropathy

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (3)

• Nephropathy and autoantibodies

  1- Relation between neuropathy and autoantibodies in lupus nephritis

  through study completion, an average of 1 year]]

• Prepherial nephropathy and systemic lupus

  Evaluate the frequency and severity of symptoms of peripheral neuropathy among patients with lupus nephritis

  through study completion, an average of 1 year]

• Electrophysiology

  Study electrophysiological properties of peripheral neuropathy and their relation to disease activity

  through study completion, an average of 1 year]]

Study Arms (3)

Inactive stage

patients diagnosed as SLE and lupus nephritis (inactive stage)

Active stage

patients diagnosed as SLE and lupus nephritis (active stage)

Control

patients control group not SLE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ):patients demographics including )age ,sex , residence , occupation,age at time of diagnosis) Full history and examination Laboratory data \& Investigations 1. CBC 2. Kidney function tests 3. ESR 4. CRP 5. urine analysis 6. screening for (HBv- HcV-HIV) 7. Autoantibodies: ANA , Anti- ds DNA 8. Rheumatoid factor 9. neuromuscular ultrasound 10 - nerve conduction

You may qualify if:

• \. Female patients
• \. Age ≥ 18 years
• \. Patients diagnosed as SLE and lupus nephritis as clinical, laboratory investigations and renal biopsy for indicated cases 4. Anti phospholipid antibodies (IgG \& IgM) 5.Associated vasculitis ( cANCA \& pANCA ) 6.Active - inactive classes of SLE 7.CKD stage I \& IV not on dialysis

You may not qualify if:

• history of viral hepatitis B or C 2.A history of malignancy (excluding basal cell carcinoma) 3.pulse therapy 4.chronic kidney disease (CKD) stage 5 or hemodialysis 5.SLE not associated with renal affect

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Marina A Fahmy

CONTACT

01093635485; asadmarina269@gmail.com

Nashwa Mo Abdel Monem

CONTACT

+20 1001543446; nashwa.azoz@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-09