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Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05688865
Enrollment
50
Registered
2023-01-18
Start date
2023-02-01
Completion date
2025-12-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Membranous Nephropathy

Keywords

glomerulonephritis

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.

Interventions

OTHERurinary markers

urinary marker testing

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
serum anti-PLA2R levels12 months
rate of renal function decline12 monthseGFR decline

Secondary

MeasureTime frame
progression to end stage kidney disease12 months

Countries

Hong Kong

Contacts

Primary ContactWinston WS Fung, MBBS
fws898@ha.org.hk35053528
Backup ContactCheuk Chun Szeto, MD
ccszeto@cuhk.edu.hk35053101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026