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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Comparison of Serum and Urinary Soluble CD163 Levels Among IgAN, FSGS, and Healthy Control Groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 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
排除标准
- •- 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
研究组 & 干预措施
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.
结局指标
主要结局
Comparison of Serum and Urinary Soluble CD163 Levels Among IgAN, FSGS, and Healthy Control Groups
时间窗: 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.
次要结局
- 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)