Membranous NephropathyNCT05688865
Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis
An observational study of Membranous Nephropathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Membranous Nephropathy
- What is being tested?
- urinary markers
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2023to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- newly diagnosed biopsy proven primary membranous glomerulonephritis
Who cannot join
- secondary causes of membranous nephropathy, e.g. lupus nephritis, viral hepatitis B and C and malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin
Mei-Shan Cheng, BN, 852-26323528, cms439@ha.org.hk
Man-Ching Law, BN, 852-26323528, lmc794@ha.org.hk
About this study
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.
Read the 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.
- Conditions
- Membranous Nephropathy
- Being tested
- urinary markers
- Keywords
- glomerulonephritis
- Medical subject headings
- Glomerulonephritis, Membranous, Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary markersOther
urinary marker testing
What is being measured
The primary outcome is the main question the study is designed to answer.
serum anti-PLA2R levels
Measured: 12 months
rate of renal function decline
eGFR decline
Measured: 12 months
Secondary outcomes (1)
progression to end stage kidney disease
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheuk-Chun SZETO, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688865
- Sponsor's protocol ID
- CRE-2022.642
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No