A Diagnostic System of Clincial Model and Urinary Biomarkers for Intrinsic Acute Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,360
- 试验地点
- 1
- 主要终点
- Histological diagnosis of AKD
研究概览
简要总结
The goal of this observational cross-sectional study is to develop a clinical diagnostic system for intrinsic acute kidney disease (AKD) to help clincians make non-invasive diagnosis when a kidney biopsy is not available. The main questions it aims to answer are:
- Can a clinical model comprised of common clinical indexes help diagnose AKD ?
- Can a combinition of several urinary biomarkers help diagnose AKD ? The study will be conducted in retrospective cohorts of patients with AKD undergoing kidney biopsy. The gold standard of the study is histological diagnosis of AKD. The model will be developed in a derivation cohort from one center, and will be further externally validated in a multicent cohort. The urinary biomarkers will only be tested in the derivation cohort.
详细描述
Acute kidney disease is a frequent syndrome characterized by a sudden loss of kidney function. AKD caused by intrinsic kidney diseases are usually more severe than other causes. The treatment of intrinsic AKD mostly depends on a definite pathological diagnosis, requiring invasive kidney biopsy which is not available in all AKD cases. The goal of this study is to develop a clinical diagnostic system comprised of clinical model and urinary biomarkers for intrinsic AKD to help clincians make non-invasive diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with AKD undergoing kidney biopsy between Jan. 1, 2020 and Dec. 31, 2024.
排除标准
- •Patients were excluede if they
- •underwent a biopsy to evaluate renal allograft rejection;
- •had a history of hematopoietic stem cell transplantation;
- •were diagnosed with hematological malignancy or end-stage tumor with kidney metastasis;
- •were tested antineutrophil cytoplasmic autoantibody (ANCA) or double-strand DNA (dsDNA) or anti-glomerular basement membrane (GBM) antibody positive before biopsy.
结局指标
主要结局
Histological diagnosis of AKD
时间窗: within a week after biopsy
Number of definite biopsy-proven histological diagnosis of AKD
次要结局
未报告次要终点