Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Recruiting

• Conditions: Membranous Nephropathy

• Registration Number: NCT05688865
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-18
• Study Start: 2023-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• newly diagnosed biopsy proven primary membranous glomerulonephritis

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum anti-PLA2R levels	12 months
rate of renal function decline	12 months	eGFR decline

Secondary Outcome Measures

Name	Time	Method
progression to end stage kidney disease	12 months

Trial Locations

Locations (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong