Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Study Overview
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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.

Official Title
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Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis

Conditions
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Membranous Nephropathy

Intervention / Treatment
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* Other: urinary markers


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: urinary markers|urinary marker testing|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum anti-PLA2R levels |  | 12 months | 
| rate of renal function decline | eGFR decline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression to end stage kidney disease |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glomerulonephritis