Clinical trial NCT05688865: Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis
Official title: Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Membranous Nephropathy
Keywords: glomerulonephritis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum anti-PLA2R levels
timeFrame: 12 months
measure: rate of renal function decline
timeFrame: 12 months
Secondary outcomes:
measure: progression to end stage kidney disease
timeFrame: 12 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital
Study officials:
References: