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NCT Number: NCT07754019

Serum and Urinary sCD163 in IgA Nephropathy

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.

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Key information

About this study

This is a single-center observational study involving patients with biopsy-proven IgA nephropathy. The study includes both retrospectively collected clinical and histopathologic data and prospectively collected follow-up data, in accordance with the approved study protocol. Serum and urinary soluble CD163 levels will be measured and evaluated in relation to demographic characteristics, kidney function, proteinuria, hematuria, and other relevant laboratory parameters.

Histopathologic severity will be assessed using kidney biopsy findings, including Oxford MEST-C classification components where available. Associations between soluble CD163 levels and markers of disease activity, histopathologic lesions, and renal outcomes will be examined. Follow-up assessments will include changes in estimated glomerular filtration rate, serum creatinine, and proteinuria, as well as other predefined renal outcomes.

No study-specific therapeutic intervention will be assigned. All treatment decisions will be made by the treating physicians according to routine clinical practice. The study is designed to investigate the potential value of serum and urinary soluble CD163 as biomarkers of disease activity, histopathologic severity, and prognosis in IgA nephropathy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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

Exclusion criteria

  • - 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

Treatment and study plan

Primary outcomes

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

    Time frame: At baseline sample collection

    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.

Secondary outcomes

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

    Time frame: At baseline assessment

    Associations of serum and urinary soluble CD163 levels with proteinuria, hematuria, serum creatinine, estimated glomerular filtration rate, and other clinical indicators of disease activity will be evaluated in participants with biopsy-proven IgA nephropathy.

  2. Association of Soluble CD163 Levels With Histopathologic Severity

    Time frame: At baseline kidney biopsy assessment

    Associations of serum and urinary soluble CD163 levels with Oxford MEST-C parameters in IgA nephropathy and with segmental sclerosis and tubulointerstitial fibrosis findings in focal segmental glomerulosclerosis will be evaluated.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Association of Serum and Urinary Soluble CD163 Levels With Disease Activity, Histopathologic Severity, and Prognosis in Patients With IgA Nephropathy: A Single-Center Observational Study

Acronym: SCD163-IgAN

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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