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NCT06288308 Clinical Trial

Fibrinogen to Albumin Ratio (FAR) as a Predictive Biomarker for Lupus Nephritis (LN)

Lupus Nephritis Clinical Trial

Official title:
Fibrinogen to Albumin Ratio as a Predictive Biomarker for Lupus Nephritis (LN)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06288308
Other study ID # FAR in lupus nephritis (LN)
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 20, 2024
Est. completion date December 2024

Study information
Verified date February 2024
Source Assiut University
Contact Ahmed Mamdouh
Phone 01154226730
Email ahmedfares1995mm@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN)

Description:

Systemic lupus erythematosus is a chronic autoimmune disease often coexists with other diseases and damages multiple organs such as kidney liver nervous system and so on. Lupus nephritis is clinically evident in 50-60% of patients with systemic lupus erythematosus and it is histologically evident in most SLE patients even those without clinical manifestations of kidney disease . The current standardized classification system for lupus nephritis is derived from the World Health Organization and the International Society of Nephrology/Renal Pathology Society's recommendations. The classification system is based on glomerular morphologic changes seen on microscopy immune deposits seen on immunofluorescence and also electronic microscopy. Class 1 - Minimal Mesangial Lupus Nephritis. Class 2 - Mesangial Proliferative Lupus Nephritis. Class 3 - Focal Lupus Nephritis. Class 4 - Diffuse Lupus Nephritis. Class 5 - Membranous Lupus Nephritis. Class 6 - Advanced Sclerosis Lupus Nephritis. Fibrinogen (FIB) is an acute time response protein rises rapidly in inflammation infection myocardial infarction and tumor. The formation and deposition of immune complexes are important mechanism of lupus nephritis the infiltrate of inflammatory cells and the release of inflammatory factors cause renal injury resulting in the decreasing concentration of albumin. The fibrinogen-to-albumin ratio as a new inflammatory marker has been proved to have good predictive value in the diagnosis and prognosis of diabetic nephropathy acute renal injury SLE disease and so on.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 90
Est. completion date December 2024
Est. primary completion date November 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. 90 Pts with SLE that have LN in different classes. 2. Age between 18-60 yrs. Exclusion Criteria: 1. Pts with ESRD, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with DM and Cancer. 2. Age below 18 yrs& above 60 yrs 3. Pt who refused to contribute in this study

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• fibronigin to albumin ratio
To investigate the association of fibrinogen to albumin ratio (FAR) with LN in different classes. b. Secondary (subsidiary): To prove the possible role of FAR as a novel diagnostic biomarker to predict LN progression

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Parikh SV, Almaani S, Brodsky S, Rovin BH. Update on Lupus Nephritis: Core Curriculum 2020. Am J Kidney Dis. 2020 Aug;76(2):265-281. doi: 10.1053/j.ajkd.2019.10.017. Epub 2020 Mar 24. — View Citation

Yap DYH, Chan TM. B Cell Abnormalities in Systemic Lupus Erythematosus and Lupus Nephritis-Role in Pathogenesis and Effect of Immunosuppressive Treatments. Int J Mol Sci. 2019 Dec 10;20(24):6231. doi: 10.3390/ijms20246231. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN) investigate the association of fibrinogen to albumin ratio (FAR) with LN and to prove its possible role as a novel biomarker to predict LN progression 1 year
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