S100A8 in Serum and Urine as a New Biomarker in Lupus Nephritis

NCT06872138 | Completed

• 1 other identifier: PT(882)
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate both serum and urine S100A8 as potential biomarkers for Lupus nephritis (LN)

Conditions

S100A8; Serum; Urine; Biomarker; Lupus; Nephritis

Outcome Measures

Primary Outcomes (1)

• Assessment of S100A8 levels in serum for diagnosing lupus nephritis (LN)

  Venous blood (5cm blood) and urine will be collected from patients with systemic lupus erythematosus (SLE) and healthy control, and the serum will be immediately centrifuged at 15,928 relative centrifugal force (RCF) and for 10 min. The supernatant will be collected and stored at -80°C until further analysis. Before the enzyme-linked immunosorbent assay (ELISA) is conducted, frozen serum samples will be thawed and then diluted 1:100 in phosphate-buffered saline. S100A8 homodimer concentrations will be measured using a commercially available ELISA kit for serum.

  3 months

Secondary Outcomes (3)

• Accessment S100A8 levels in urine for diagnosing lupus nephritis (LN)

  3 months

• Correlation between S100A8 level and disease activity markers

  3 months

• Using S100A8 as a predictor for renal affection in systemic lupus erythematosus (SLE) patients for follow up and early treatment.

  3 months

Study Arms (2)

Systemic lupus erythematosus (SLE) Group

Systemic lupus erythematosus (SLE) patients. Group I will be subdivided into two groups: Group IA (n=30): SLE patients with lupus nephritis (LN) Group IB (n=20): SLE patients without LN.

Control Group

Age and sex matched healthy control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were stratified into two main groups: Group I consisted of 50 SLE patients, further subdivided into Group IA (n=30) with LN and Group IB (n=20) without LN. Group II comprised 20 age- and sex-matched healthy controls.

You may qualify if:

• Age ≥ 18 years.
• Both sexes.
• Patients with Systemic lupus erythematosus (SLE)
• Patients with SLE and renal affection. SLE diagnosis is based on the 1997 American College of Rheumatology (ACR) criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.
• Renal involvement (lupus Nephritis) (LN) can be diagnosed by presence of proteinurea or elevated kidney function and can be confirmed by biopsy if present.

You may not qualify if:

• Autoimmune diseases.
• Sjogren's syndrome.
• Rheumatoid arthritis.
• Systemic sclerosis.
• Taking other biologic disease-modifying anti-rheumatic drugs.
• Immunosuppressive drugs.
• Corticosteroid.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 12411, Egypt

Location

MeSH Terms

Conditions

Nephritis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nephrology, Theodor Bilharz Research Institute (TBRI), Giza, Egypt

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: November 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding autho

Locations

EG (1)