Serum and Urinary sCD163 in IgA Nephropathy

NCT07754019 | Active Not Recruiting

• 1 other identifier: IGAN-SCD163-2026
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy is a common primary glomerular disease with a highly variable clinical course. Soluble CD163 is a marker associated with monocyte and macrophage activation and may reflect inflammatory activity in kidney disease. This single-center observational study aims to evaluate the associations of serum and urinary soluble CD163 levels with clinical disease activity, histopathologic severity, and renal prognosis in patients with IgA nephropathy. Clinical, laboratory, and kidney biopsy findings will be assessed together with serum and urinary soluble CD163 measurements. Participants will also be followed for renal outcomes, including changes in kidney function and proteinuria. The study is expected to clarify whether soluble CD163 may serve as a noninvasive biomarker of disease activity and prognosis in IgA nephropathy.

Conditions

IgA Nephropathy

Keywords

Soluble CD163; Oxford MEST-C Classification; Proteinuria; Renal Prognosis; sCD163; Urinary Biomarker; Serum Biomarker; IgA Nephropathy; Kidney Biopsy

Outcome Measures

Primary Outcomes (1)

• Comparison of Serum and Urinary Soluble CD163 Levels Among IgAN, FSGS, and Healthy Control Groups

  Serum soluble CD163 concentration, urinary soluble CD163 concentration, and urinary soluble CD163 normalized to urinary creatinine will be compared among participants with biopsy-proven IgA nephropathy, participants with biopsy-proven focal segmental glomerulosclerosis, and healthy controls. Soluble CD163 levels will be measured using a commercially available ELISA kit.

  At baseline sample collection

Secondary Outcomes (2)

• Association of Soluble CD163 Levels With Clinical Disease Activity in IgA Nephropathy

  At baseline assessment

• Association of Soluble CD163 Levels With Histopathologic Severity

  At baseline kidney biopsy assessment

Study Arms (3)

Patients With Biopsy-Proven IgA Nephropathy

Patients with biopsy-proven IgA nephropathy who undergo assessment of serum and urinary soluble CD163 levels together with clinical, laboratory, histopathologic, and follow-up data. No study-specific therapeutic intervention is assigned, and treatment decisions are made according to routine clinical practice.

Patients With Biopsy-Proven FSGS

Patients with biopsy-proven focal segmental glomerulosclerosis who undergo assessment of serum and urinary soluble CD163 levels together with relevant clinical, laboratory, histopathologic, and follow-up data. This group serves as a disease control group. No study-specific therapeutic intervention is assigned.

Healthy Controls

Healthy individuals without known kidney disease who undergo serum and urinary soluble CD163 measurement and relevant clinical and laboratory assessment. This group serves as a healthy control group.

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

Adults aged 18 years or older followed at Bezmialem Vakif University with biopsy-proven primary IgA nephropathy or primary focal segmental glomerulosclerosis, together with age- and sex-matched healthy controls without known chronic disease and with normal kidney function. Clinical, laboratory, histopathologic, biomarker, treatment, and follow-up data will be collected according to the approved observational study protocol.

You may qualify if:

• \- Age 18 years or older
• Biopsy-proven primary IgA nephropathy or primary focal segmental glomerulosclerosis
• Stable kidney function with an estimated glomerular filtration rate greater than 30 mL/min/1.73 m²
• Availability of serum and urine samples for soluble CD163 measurement
• Availability of relevant demographic, clinical, laboratory, histopathologic, and follow-up data
• For the healthy control group: age- and sex-matched individuals without known chronic disease and with normal kidney function
• Written informed consent

You may not qualify if:

• \- Secondary IgA nephropathy or secondary focal segmental glomerulosclerosis
• Active infection
• Acute kidney injury
• End-stage kidney disease or ongoing dialysis treatment
• Estimated glomerular filtration rate below 15 mL/min/1.73 m²
• Recent use of corticosteroids or immunosuppressive therapy
• Pregnancy
• Active malignancy or history of malignancy
• Inadequately stored or unavailable serum and/or urine samples
• Missing essential clinical, laboratory, histopathologic, or follow-up data
• Absence of written informed consent

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University Health Application and Research Center

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

• Gong S, Jin S, Li Y, Jiang W, Zhang Z, Shen Z, Wang J, Zhou H, Liu X, Xu X, Ding X, Shi Y, Liu H. Urinary Soluble CD163 Levels Predict IgA Nephropathy Remission Status. Front Immunol. 2021 Dec 23;12:769802. doi: 10.3389/fimmu.2021.769802. eCollection 2021.

  PMID: 35003086 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine samples collected for measurement of soluble CD163 and related laboratory analyses. Stored serum and urine samples may be used for study-related biomarker analyses in accordance with the approved protocol and informed consent.

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Omer Celal Elcioglu, Professor

  Bezmialem Vakif University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: February 3, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)