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

February 24, 2024 updated by: Ahmed Mamdouh Mohamed Fares, Assiut University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Sample size was calculated using EPI info 2000 statistical package:- 60 patients diagnosed with LN depending on lab criteria and imaging are submitted for this study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN)
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 12, 2023

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Estimated)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAR in lupus nephritis (LN)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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