Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

NCT05688865 — Recruiting, 50 participants, Chinese University of Hong Kong

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RegistryNCT05688865
StatusRecruiting
Study typeObservational
Enrollment50 (Estimated)
SponsorChinese University of Hong Kong (Other)
ConditionsMembranous Nephropathy
Interventionsurinary markers (Other)
Datesstart 2023-02-01, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2023-01-18, last updated 2026-10-21
Locations1 site in Hong Kong

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-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.

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+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.

+Arms and interventions

  • urinary markers (Other): urinary marker testing

+Outcome measures

Primary outcomes

  • serum anti-PLA2R levels [12 months]
  • rate of renal function decline [12 months]: eGFR decline

Secondary outcomes

  • progression to end stage kidney disease [12 months]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Department of Medicine & Therapeutics, Prince of Wales HospitalShatinHong KongRecruiting