Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05688865
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-01-08
Brief Title:
Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Correlation and Clinical Utility of Urinary Biomarker in Membranous Glomerulonephritis
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None