NCT06288308

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

November 12, 2023

Last Update Submit

February 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Pts with SLE that have LN in different classes.
  • Age between 18-60 yrs.

You may not qualify if:

  • Pts with ESRD, manifested cardiac valvular disease, acute infection, history of hepatitis, pts with DM and Cancer.
  • Age below 18 yrs\& above 60 yrs
  • Pt who refused to contribute in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 32220510BACKGROUND
  • 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.

    PMID: 31835612BACKGROUND

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

November 12, 2023

First Posted

March 1, 2024

Study Start

March 20, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02