Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

NCT05688865 | Recruiting

• 1 other identifier: CRE-2022.642
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Membranous Nephropathy

Keywords

glomerulonephritis

Outcome Measures

Primary Outcomes (2)

• serum anti-PLA2R levels

  12 months

• rate of renal function decline

  eGFR decline

  12 months

Secondary Outcomes (1)

• progression to end stage kidney disease

  12 months

Interventions

urinary markers OTHER

urinary marker testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We aim to recruit 50 patients with newly diagnosed biopsy proven primary membranous glomerulonephritis. The pathologic diagnosis of membranous nephropathy is made by light microscopy, immunofluorescence including PLA2R/ THSD7A staining and electron microscopy. Secondary causes would be excluded after extensive clinical workup including detailed medical history and patient examination, serological markers of systemic autoimmunity. Essentially, lupus nephritis, viral hepatitis B and C and malignancy would be excluded. The severity of the primary membranous glomerulonephritis is defined according to the KDIGO clinical practice guideline on glomerular diseases.

You may qualify if:

• newly diagnosed biopsy proven primary membranous glomerulonephritis

You may not qualify if:

• secondary causes of membranous nephropathy, e.g. lupus nephritis, viral hepatitis B and C and malignancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine & Therapeutics, Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urinary cell-free DNA fragments

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Glomerulonephritis

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Winston WS Fung, MBBS

CONTACT

35053528; fws898@ha.org.hk

Cheuk Chun Szeto, MD

CONTACT

35053101; ccszeto@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine & Therapeutics

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)