Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

NCT ID: NCT05688865

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Membranous Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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urinary markers

urinary marker testing

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Cheuk-Chun SZETO

Professor, Department of Medicine & Therapeutics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Winston WS Fung, MBBS

Role: CONTACT

Cheuk Chun Szeto, MD

Role: CONTACT

Facility Contacts

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Mei-Shan Cheng, BN

Role: primary

852-26323528

Man-Ching Law, BN

Role: backup

852-26323528

Other Identifiers

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CRE-2022.642

Identifier Type: -

Identifier Source: org_study_id

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