Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642402
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Monitoring Lupus Nephritis Through Urinary Extracellular Vesicles
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Monitoring and Detecting Lupus Nephritis Through Urinary Extracellular Vesicles in Urine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lupus nephritis LN is a severe manifestation of systemic lupus erythematosus SLE that can lead to irreversible kidney damage if not detected and managed promptly LN is classified and treated based on its histopathological features obtained by invasive kidney biopsy Recent research has suggested urinurinary extracellular vesicles uEVs as potential non-invasive biomarkers The primary objective of this prospective study is to investigate the utility of uEVs in LN
Detailed Description:
Introduction Lupus nephritis LN is a severe manifestation of systemic lupus erythematosus SLE that can lead to irreversible kidney damage if not detected and managed promptly LN is classified based on its histopathological features The classification helps in determining the severity and appropriate treatment strategies for the condition and to rule out other conditions that may mimic the clinical picture of LN The classification system most commonly used is the International Society of NephrologyRenal Pathology Society ISNRPS classification which divides lupus nephritis into six classes I Minimal Change II Mesangial Proliferative LN III Focal Proliferative LN IV Diffus proliferative LN V Membranous LN VI Advanced Sclerosing LN2 The classification requires invasive kidney biopsies which are hardly accessible and associated with potential complications and patient discomfort Furthermore the kidney biopsies only represent a small part of the kidney Recent research has suggested urinary extracellular vesicles uEVs as potential non-invasive biomarkers for kidney diseases including LN4 uEVS are small nano-sized extracellular vesicles of endosomal origin which are secreted into the urine through fusion of multivesicular bodies with the plasma membrane Thus they could represent a promising liquid biopsy that reflects the pattern andor severity of renal histologic injury
Hypothesis The primary objective of this prospective study is to investigate the utility of urinary exosomes as a non-invasive biomarker for monitoring the activity and progression of lupus nephritis in SLE patients
Methods SLE patients fulfilling the 2019 EULARACR classification criteria referred to kidney biopsy will be recruited from Department of Rheumatology and Department of Nephrology at Odense University Hospital Detailed demographic and clinical data including age sex ethnicity medicine duration of SLE activity SLE damage and laboratory results will be collected from each patient Activity of SLE at the time of biopsy will be evaluated using SLE disease activity index 2000 SLEDAI-2K SLE damage will be evaluated in accordance with the SLICC damage index Spot-urine samples will be collected added protease-inhibitors and frozen at -80 degree UEVs will be isolated using polyethylene glycol PEG precipitation the concentration of uEV will be determined and protein accessed using western blotting andor PCR Glomerular specific uEVs will be isolated and previous developed tests will be applied to detect the membrane attack complex MACC5b-9 complex5 uEVs from plasmaserum will be isolated to test for correlation with uEVs Kidney biopsies will be histological analyzed at department of Pathology by experienced nephro-pathologists according to existing clinical guidelines Differences in uEV cargo between SLE patients with and without lupus nephritis will be analyzed using appropriate statistical tests Correlations between exosomal biomarkers histological differences on the kidney biopsy and disease activity will be evaluated using Pearsons correlation analysis
Perspective This prospective study aims to establish urinary exosomes as potential non-invasive biomarkers for monitoring lupus nephritis in SLE patients The findings from this research may lead to the development of more efficient and patient-friendly approaches for LN management enabling timely interventions and improved renal outcomes in SLE patients
Hypothesis The primary objective of this prospective study is to investigate the utility of urinary exosomes as a non-invasive biomarker for monitoring the activity and progression of lupus nephritis in SLE patients
Methods SLE patients fulfilling the 2019 EULARACR classification criteria referred to kidney biopsy will be recruited from Department of Rheumatology and Department of Nephrology at Odense University Hospital Detailed demographic and clinical data including age sex ethnicity medicine duration of SLE activity SLE damage and laboratory results will be collected from each patient Activity of SLE at the time of biopsy will be evaluated using SLE disease activity index 2000 SLEDAI-2K SLE damage will be evaluated in accordance with the SLICC damage index Spot-urine samples will be collected added protease-inhibitors and frozen at -80 degree UEVs will be isolated using polyethylene glycol PEG precipitation the concentration of uEV will be determined and protein accessed using western blotting andor PCR Glomerular specific uEVs will be isolated and previous developed tests will be applied to detect the membrane attack complex MACC5b-9 complex5 uEVs from plasmaserum will be isolated to test for correlation with uEVs Kidney biopsies will be histological analyzed at department of Pathology by experienced nephro-pathologists according to existing clinical guidelines Differences in uEV cargo between SLE patients with and without lupus nephritis will be analyzed using appropriate statistical tests Correlations between exosomal biomarkers histological differences on the kidney biopsy and disease activity will be evaluated using Pearsons correlation analysis
Perspective This prospective study aims to establish urinary exosomes as potential non-invasive biomarkers for monitoring lupus nephritis in SLE patients The findings from this research may lead to the development of more efficient and patient-friendly approaches for LN management enabling timely interventions and improved renal outcomes in SLE patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None