Bezmialem Vakif University Health Application and Research Center
Istanbul, 34093, Turkey (Türkiye)
NCT Number: NCT07754019
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 study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Istanbul, 34093, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Bezmialem Vakif University
Other
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
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