NCT06520670

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

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
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 20, 2024

Last Update Submit

July 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Level of galectin_3 binding protein in urine samples .

    Level of galectin\_3binding protein in urine samples by pg/mmol using ELISA in patient with lupus nephritis.

    baseline

Study Arms (3)

Patient with Lupus nephritis diagnosed by biopsy.

Diagnostic Test: Urinary galectin-3 binding protein

Patient with SLE without nephritis.

Diagnostic Test: Urinary galectin-3 binding protein

Patient with nephritis of other reasons

Patient with nephritis of other reasons; acute proliferative glomerulonephritis (postinfectious and infection associated), crescentic glomerulonephritis, else.

Diagnostic Test: Urinary galectin-3 binding protein

Interventions

Investigate urinary galectin-3 binding protein (G3BP) as a biomarker for lupus nephritis and indicator for disease activity.

Patient with Lupus nephritis diagnosed by biopsy.Patient with SLE without nephritis.Patient with nephritis of other reasons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

males and females that are not pregnant of any age above 18 years have one of next criteria: * Patient with Lupus nephritis diagnosed by biopsy. * Patient with SLE without nephritis. * Patient with nephritis of other reasons; acute proliferative glomerulonephritis (postinfectious and infection associated), crescentic glomerulonephritis, else. All patients were selected from outpatient clinic of rheumatology and inpatient wards of Internal Medicine Department Assiut University Hospitals. The patients will be interviewed, and those who agreed to share in the study were selected. An informed consent was obtained from each patient to be enrolled in the study.

You may qualify if:

  • Any age above 18 years.
  • Patient with Lupus nephritis diagnosed by biopsy.
  • Patient with SLE without nephritis.
  • Patient with nephritis of other reasons; acute proliferative glomerulonephritis (postinfectious and infection associated), crescentic glomerulonephritis, else.

You may not qualify if:

  • Pregnant.
  • Patient who refused to be part of the study.
  • Patients with estimated Glomerular Filtration Rate less than 15ml/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Azza Mh Hussien, master

CONTACT

Rasha Ah madkor

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 20, 2024

First Posted

July 25, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

July 26, 2024

Record last verified: 2024-07