Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654024
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Urinary Congophilia As an Indicator of Activity of Lupus Nephritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Urinary Congophilia As an Indicator of Disease Activity of Lupus Nephritis
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:
lupus nephriti
Brief Summary:
Evaluation of the impact of SLE on urinary levels of congophilia and their relationship to renal histopathology and activity of lupus nephritis LN
Detailed Description:
Systemic lupus erythematosus SLE is an inflammatory autoimmune disease that can affect all body organs The reported lifetime incidence of lupus nephritis LN in SLE patients is 20- 60 and it is histologically evident in most SLE patients even without clinical manifestations of kidney disease
Lupus nephritis is associated with higher mortality as within 5 years of diagnosis between 10 and 30 percent of these people develop end-stage renal disease Early detection and treatment of lupus nephritis can significantly improve renal outcomes and decrease overall mortality
Endoplasmic reticulum ER stress proteins which act as protein quality control factors in the secretory pathway in the cell are induced by ER stress in inflammatory lesions and also participate in autoimmunity and inflammation processes ER stress proteins are expressed not only in the ER but also occasionally at the cell surface that plays pathophysiological roles in autoimmune and inflammatory diseases as pro- or anti-inflammatory factors Protein folding is easily impaired misfolding by different cytotoxic stresses as inflammation or hypoxia that may contribute to disease pathogenesis by either reducing the biological activity of the protein or due to toxicity by the misfolded proteins The detection of the abnormally misfolded proteins using the Congo red stain is referred to as congophilia Urinary congophilia was assessed by Congo Red Dot Blot CRDB Assay Congo red is a synthetic diazo dye with specific affinity for β-sheets of amyloid fibrils of misfolded proteins In addition to the simplicity of congophilia based dot blot technique the non-invasiveness of the method is useful in adapting the CRDB assay for self-collected urine samples
One previous study in pregnant females with lupus nephritis said that urinary congophilia has a diagnostic value in patients with lupus nephritis and can be used as a reliable marker of disease activity as the presence of urinary congophilia biomarker is related to disease activity rather than pregnancy
Lupus nephritis is associated with higher mortality as within 5 years of diagnosis between 10 and 30 percent of these people develop end-stage renal disease Early detection and treatment of lupus nephritis can significantly improve renal outcomes and decrease overall mortality
Endoplasmic reticulum ER stress proteins which act as protein quality control factors in the secretory pathway in the cell are induced by ER stress in inflammatory lesions and also participate in autoimmunity and inflammation processes ER stress proteins are expressed not only in the ER but also occasionally at the cell surface that plays pathophysiological roles in autoimmune and inflammatory diseases as pro- or anti-inflammatory factors Protein folding is easily impaired misfolding by different cytotoxic stresses as inflammation or hypoxia that may contribute to disease pathogenesis by either reducing the biological activity of the protein or due to toxicity by the misfolded proteins The detection of the abnormally misfolded proteins using the Congo red stain is referred to as congophilia Urinary congophilia was assessed by Congo Red Dot Blot CRDB Assay Congo red is a synthetic diazo dye with specific affinity for β-sheets of amyloid fibrils of misfolded proteins In addition to the simplicity of congophilia based dot blot technique the non-invasiveness of the method is useful in adapting the CRDB assay for self-collected urine samples
One previous study in pregnant females with lupus nephritis said that urinary congophilia has a diagnostic value in patients with lupus nephritis and can be used as a reliable marker of disease activity as the presence of urinary congophilia biomarker is related to disease activity rather than pregnancy
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