Serum and Urinary sCD163 in IgA Nephropathy

N/AActive Not RecruitingNCT07754019

Bezmialem Vakif University87 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

IgA Nephropathy

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: At baseline sample collection

Secondary Outcomes

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

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.

Time frame: At baseline assessment

Association of Soluble CD163 Levels With Histopathologic Severity

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.

Time frame: At baseline kidney biopsy assessment