Renal Resistive Index as an Indicator of Lupus Nephritis Severity and Systemic Lupus Activity

December 27, 2024 updated by: Tarek Samy Abdelaziz, Kasr El Aini Hospital
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

we have recruited patients into 3 groups The first group is patients with lupus nephritis The second groups is patients with systemic lupus erythromatosus without nephritis The third groups is normal healthy controls we explored the association of colour Doppler and the renal resistive index with the degree of the renal affection in lupus nephritis

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Hospitals

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with lupus nephritis
Theses are 25 patients diagnosed with lupus nephritis
Diagnostic test: colour doppler of the renal artery and measurement of resistive index
using colour doppler to asses vascular resistance and resistive index
Active Comparator: Lupus without nephritis
Theses are 25 patients diagnosed with lupus without evidence of nephritis
Diagnostic test: colour doppler of the renal artery and measurement of resistive index
using colour doppler to asses vascular resistance and resistive index
No Intervention: Healthy control
Patients who are healthy volunteers with no evidence of nephritis or systemic lupus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistive index
Time Frame: At the time of recruitment
The resistive index of the renal arteries as measured by the colour Doppler
At the time of recruitment

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

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 (Actual)

September 3, 2022

Primary Completion (Actual)

October 13, 2023

Study Completion (Actual)

October 15, 2023

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-632-2022 (Other Identifier: Cairo University hospitals)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Can be shared upon reasonable request

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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