Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520670
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-20
Brief Title:
Urinary G3BP as a Novel Biomarker in Lupus Nephritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Urinary galectin_3 Binding Protein as a Novel Biomarker in Lupus Nephritis and Indicator for Disease Activity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Estimation of urinary Galectin-3 binding protein u-Gal-3BP in patients with systemic lupus erythematosus with and without lupus nephritis and in glomerulonephritis for other kidney diseases Find the relation of urinary Galectin-3 binding protein u-Gal-3BP levels with lupus nephritis and Correlate urinary Galectin-3 binding protein u-Gal-3BP levels with SLE disease activity
Detailed Description:
Systemic lupus erythematosus SLE is a systemic autoimmune disease with multisystem involvement The condition has several phenotypes with varying clinical presentations from mild mucocutaneous manifestations to multiorgan and severe central nervous system involvement Several immunopathogenic pathways play a role in the development of SLE Hargraves described the lupus erythematosus LE cell in 1948 Several pathogenic autoantibodies have since been identified Despite recent advances in technology and understanding of the pathological basis and risk factors for SLE the exact pathogenesis is still not well known Diagnosis of SLE can be challenging and while several classification criteria have been posed their utility in the clinical setting is still a matter of debate Management of SLE is dictated by organ system involvement Despite several agents shown to be efficacious in treating SLE the disease still poses significant morbidity and mortality risk in patients
Lupus nephritis LN is a highly prevalent and serious clinical manifestation among patients with systemic lupus erythematosus SLE It affects up to 60 of patients depending on the examined cohort Although SLE management has improved LN still represents a difficult to treat manifestation with renal flares occurring in about half of the patients and development of end stage renal disease ESRD in 520 of patients
Lupus nephritis directly contributes to SLE-related mortality both in the early and later disease phase
Lupus nephritis diagnosis relies on kidney biopsy which is instrumental for histological characterization and treatment decisions However the biopsy procedure is invasive often associated with discomfort for the patient and sometimes with bleeding complications Although repeated biopsies have been shown to be of value their utility still remains controversial for verifying treatment effects monitoring disease and predicting outcomes in clinical practice
In this context it is highly desirable to identify new non-invasive biomarkers that may reflect the type of kidney involvement reflect the degree of histological activity and damage predict LN flares and be useful for assessing treatment response In this respect urinary biomarkers are of high relevance since they can serve as liquid biopsy and reveal pathogenic events taking place in the kidney
the investigators investigated urinary Galectin-3 binding protein u-Gal-3BP as a novel candidate biomarker for disease activity in renal lupus here studied in a real life SLE cohort
Gal-3BP is an interferon-inducible secreted scavenger protein belonging to the lectin family in SLE previous studies have demonstrated high expression of Gal-3BP in blood both in systemic and cutaneous forms of lupus and the protein was found in circulating macrovesicles as well as in macrovesicles in the context of immune deposits in the kidney
Lupus nephritis LN is a highly prevalent and serious clinical manifestation among patients with systemic lupus erythematosus SLE It affects up to 60 of patients depending on the examined cohort Although SLE management has improved LN still represents a difficult to treat manifestation with renal flares occurring in about half of the patients and development of end stage renal disease ESRD in 520 of patients
Lupus nephritis directly contributes to SLE-related mortality both in the early and later disease phase
Lupus nephritis diagnosis relies on kidney biopsy which is instrumental for histological characterization and treatment decisions However the biopsy procedure is invasive often associated with discomfort for the patient and sometimes with bleeding complications Although repeated biopsies have been shown to be of value their utility still remains controversial for verifying treatment effects monitoring disease and predicting outcomes in clinical practice
In this context it is highly desirable to identify new non-invasive biomarkers that may reflect the type of kidney involvement reflect the degree of histological activity and damage predict LN flares and be useful for assessing treatment response In this respect urinary biomarkers are of high relevance since they can serve as liquid biopsy and reveal pathogenic events taking place in the kidney
the investigators investigated urinary Galectin-3 binding protein u-Gal-3BP as a novel candidate biomarker for disease activity in renal lupus here studied in a real life SLE cohort
Gal-3BP is an interferon-inducible secreted scavenger protein belonging to the lectin family in SLE previous studies have demonstrated high expression of Gal-3BP in blood both in systemic and cutaneous forms of lupus and the protein was found in circulating macrovesicles as well as in macrovesicles in the context of immune deposits in the kidney
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