跳至主要内容
临床试验/NCT05688865
NCT05688865招募中不适用

Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
serum anti-PLA2R levels

研究概览

简要总结

To assess the correlation of these urinary biomarkers with the serum sample and evaluated the clinical utility of using urinary sample in the detection and prognostication of MGN. Fifty patients with newly diagnosed biopsy proven MGN would be recruited and followed up for 1 years. Serum and urinary biomarkers would be collected every 4 months and their antibody titres measured with ELISA assay.

详细描述

The uses of phospholipase A2 receptor and thrombospondin domain containing 7A antibodies have transformed the management of membranous glomerulonephritis (MGN). However, these are mostly based on serum and the utility of urinary biomarkers are yet to be established.

The aim of this study is to assess the correlation of these urinary biomarkers with the serum sample and evaluated the clinical utility of using urinary sample in the detection and prognostication of MGN. Fifty patients with newly diagnosed biopsy proven MGN would be recruited and followed up for 1 years. Serum and urinary biomarkers would be collected every 4 months and their antibody titres measured with ELISA assay.

The primary outcome would be the correlation of the urinary biomarkers with the corresponding serum markers. The secondary outcome would be the correlation of the urinary biomarkers with clinical parameters such as the slope of eGFR decline, composite renal events such as time to need for renal replacement therapy or renal death and response to treatments.

By establishing the clinical correlation of these urinary biomarkers, the use of such biomarkers would be a more attractive option given its non-invasive nature and conveniences as compared to serum samples.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed biopsy proven primary membranous glomerulonephritis

排除标准

  • secondary causes of membranous nephropathy, e.g. lupus nephritis, viral hepatitis B and C and malignancy

结局指标

主要结局

serum anti-PLA2R levels

时间窗: 12 months

rate of renal function decline

时间窗: 12 months

eGFR decline

次要结局

  • progression to end stage kidney disease(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheuk-Chun SZETO

Professor, Department of Medicine & Therapeutics

Chinese University of Hong Kong

研究点 (1)

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