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Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Enrolling

Conditions

Membranous Nephropathy

Treatments

Other: urinary markers

Study type

Observational

Funder types

Other

Identifiers

NCT05688865
CRE-2022.642

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Cheuk Chun Szeto, MD; Winston WS Fung, MBBS

Data sourced from clinicaltrials.gov

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