NCT06757725

Brief Summary

The study explores the role of the colour Doppler scanning of the renal arteries and its relation to the degree of disease affection in lupus nephritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 3, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

December 27, 2024

Last Update Submit

December 27, 2024

Conditions

Systemic Lupus ErthematosusLupus GlomerulonephritisLupus Flare

Keywords

systimc lupus erythromatosuslupus glomerulonephritis

Outcome Measures

Primary Outcomes (1)

  • Resistive index

    The resistive index of the renal arteries as measured by the colour Doppler

    At the time of recruitment

Study Arms (3)

Patients with lupus nephritis

ACTIVE COMPARATOR

Theses are 25 patients diagnosed with lupus nephritis

Diagnostic Test: colour doppler of the renal artery and measurement of resistive index

Lupus without nephritis

ACTIVE COMPARATOR

Theses are 25 patients diagnosed with lupus without evidence of nephritis

Diagnostic Test: colour doppler of the renal artery and measurement of resistive index

Healthy control

NO INTERVENTION

Patients who are healthy volunteers with no evidence of nephritis or systemic lupus

Interventions

colour doppler of the renal artery and measurement of resistive indexDIAGNOSTIC_TEST

using colour doppler to asses vascular resistance and resistive index

Lupus without nephritisPatients with lupus nephritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Systemic lupus erythematosus. 2. Lupus nephritis. 3. Adults \>18 years old.

You may not qualify if:

  • \. End Stage Renal Disease. 2. Diabetes Mellitus. 3. Heart failure. 4. Hepatic diseases. 5. Obstructive nephropathy. 6. Renal artery stenosis or occlusion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Internal medicine and nephrology

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 3, 2025

Study Start

September 3, 2022

Primary Completion

October 13, 2023

Study Completion

October 15, 2023

Last Updated

January 3, 2025

Record last verified: 2024-12

Locations

EG(1)