Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

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.

Study Overview

• Status: Recruiting
• Conditions: Membranous Nephropathy
• Intervention / Treatment: Other: urinary markers

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Winston WS Fung, MBBS; Phone Number: 35053528; Email: fws898@ha.org.hk
• Study Contact Backup: Name: Cheuk Chun Szeto, MD; Phone Number: 35053101; Email: ccszeto@cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Department of Medicine & Therapeutics, Prince of Wales Hospital
    • Contact: Mei-Shan Cheng, BN; Phone Number: 852-26323528; Email: cms439@ha.org.hk
    • Contact: Man-Ching Law, BN; Phone Number: 852-26323528; Email: lmc794@ha.org.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

We aim to recruit 50 patients with newly diagnosed biopsy proven primary membranous glomerulonephritis. The pathologic diagnosis of membranous nephropathy is made by light microscopy, immunofluorescence including PLA2R/ THSD7A staining and electron microscopy. Secondary causes would be excluded after extensive clinical workup including detailed medical history and patient examination, serological markers of systemic autoimmunity. Essentially, lupus nephritis, viral hepatitis B and C and malignancy would be excluded. The severity of the primary membranous glomerulonephritis is defined according to the KDIGO clinical practice guideline on glomerular diseases.

Description

Inclusion Criteria:

• newly diagnosed biopsy proven primary membranous glomerulonephritis

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum anti-PLA2R levels		12 months
rate of renal function decline	eGFR decline	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
progression to end stage kidney disease	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: glomerulonephritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Nephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Glomerulonephritis, Membranous
• Other Study ID Numbers: CRE-2022.642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No