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RecruitingNCT05688865

Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Status
Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Chinese University of Hong Kong · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERurinary markersurinary marker testing

Timeline

Start date
2023-02-01
Primary completion
2024-12-31
Completion
2025-12-31
First posted
2023-01-18
Last updated
2024-05-10

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT05688865. Inclusion in this directory is not an endorsement.