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Clinical Trials/NCT05688865
NCT05688865
Recruiting
Not Applicable

Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Chinese University of Hong Kong1 site in 1 country50 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Membranous Nephropathy
Sponsor
Chinese University of Hong Kong
Enrollment
50
Locations
1
Primary Endpoint
serum anti-PLA2R levels
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cheuk-Chun SZETO

Professor, Department of Medicine & Therapeutics

Chinese University of Hong Kong

Eligibility Criteria

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

Outcomes

Primary Outcomes

serum anti-PLA2R levels

Time Frame: 12 months

rate of renal function decline

Time Frame: 12 months

eGFR decline

Secondary Outcomes

  • progression to end stage kidney disease(12 months)

Study Sites (1)

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