Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Membranous Nephropathy Clinical Trial

Official title:

Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688865
• Other study ID #: CRE-2022.642
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Chinese University of Hong Kong
• Contact: Winston WS Fung, MBBS
• Phone: 35053528
• Email: fws898[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, Membranous
• Membranous Nephropathy

Intervention

Other:
• urinary markers
urinary marker testing

Locations

Country	Name	City	State
Hong Kong	Department of Medicine & Therapeutics, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum anti-PLA2R levels		12 months
Primary	rate of renal function decline	eGFR decline	12 months
Secondary	progression to end stage kidney disease		12 months