NCT05861869Enrolling By Invitation不适用
Clinical Trial of PLA2R-IgG4 Detection Kit (Time-resolved Fluorescence Immunoassay)
Zhejiang Biostar Biotechnology Co.1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2023年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Content of anti-PLA2r IgG4
研究概览
简要总结
The goal of this observational clinical trial is to compare assessment reagents with clinical diagnostic criteria in patients with membranous nephropathy. The main questions it aims to answer are:
- Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy.
- Evaluating whether the clinical diagnostic performance of the test reagent meets the requirements for auxiliary diagnosis of membranous nephropathy.
Participants will provide approximately 4ml of blood. Researchers will compare the levels of anti-PLA2RIgG4 in patients with membranous nephropathy and patients with other renal diseases,to see if there is a significant difference.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PLA2R-induced membranous nephropathy group
- •Pathological examination showed that patients with membranous nephropathy were positive for PLA2R by immunohistochemistry, and the symptoms were not completely relieved; (24 h urine protein quantification<0.3g or urine protein /creatinine (uPCR)<300mg /g is regarded as complete remission)
- •In patients with nephrotic syndrome (serum albumin ≤ 30.0g /L, clinical manifestations show moderate to large amount of proteinuria (urine protein>3.5g /L or urine protein /creatinine ratio ≥ 3500mg /g), and their serum anti PLA2R antibody detection shows positive.
- •Secondary membranous nephropathy group Patients in nephrology department who have ruled out primary membranous nephropathy.
- •the patient has the remaining serum samples of normal test, and the serum volume of the sample is not less than 1ml.
排除标准
- •The amount of centrifuged serum sample after blood collection is less than 1ml or the amount of residual serum in normal test is less than 1ml;
- •Non-serum samples, plasma samples;
- •Patients with mental or cognitive disorders;
- •No samples with definite clinical diagnosis;
- •Samples with incomplete information.
结局指标
主要结局
Content of anti-PLA2r IgG4
时间窗: through study completion, an average of 1 year
Evaluating the sensitivity and specificity of the test reagent in the diagnosis of membranous nephropathy
次要结局
未报告次要终点
研究者
研究点 (1)
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