Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients

October 7, 2024 updated by: Doaa Rabea Abdelkarim, Sohag University

Systemic Lupus Erthymatosous (SLE) is achronic inflammatory multi system auto immue disease characterized by pathogenic auto anti bodies production against nuclear structures (Bolouri et al.,2022), SLE affecting mainly woemn of childbearing age and is chracterized by unpredictable flares and remissions , disease variety varied from mild episode disorder to arpidly progressive life -threatening illness..

LN is diagnosed by either the presence of proteinuria >0.5g/day. active urinary sediment , or an unexplained rise in serum creatinine there fore , identifying new invasive biomarkers of LN severity and outcome is mandatory, Renal Arterial resistive index ( RRI) is anon invasive biomarker that has been studied as apotential indicator of disease activity in LN patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

55

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

  • Name: Esam M Abualfadl, professor

Study Locations

  • Egypt
      • Sohag, Egypt, Sohag
        • Recruiting
        • Sohag university hospital
        • Contact:
          • Magdy M Amin, professor

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

Probability Sample

Study Population

Aged ≥18 years.

  • SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls.
  • Patients cooperative and can answer questions.
  • Patients who are able and willing to give written informed consent.

Description

Inclusion Criteria:

  • Aged ≥18 years.
  • SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) classification criteria and matched controls.
  • Patients cooperative and can answer questions.
  • Patients who are able and willing to give written informed consent.

Exclusion Criteria:

  • • Individuals with other autoimmune diseases.

    • Diabetes.
    • Hypertension.
    • Heart failure.
    • Hepatic diseases.
    • Chronic renal failure.
    • Renal artery stenosis.
    • Renal vein thrombosis.
    • Intrarenal arteriovenous fistula.
    • Obstructive nephropathy.
    • Urinary tract obstruction that could affect RI of intra renal arteries.
    • Un cooperative patients.
    • Patients not able and willing to give written informed consent.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group SLE
Patients with SLE
Diagnostic test: renal doppler
doppler srudy on renal arteries bilaterally , and detection of RI of renal artery
group control
matched healthy subjects
Diagnostic test: renal doppler
doppler srudy on renal arteries bilaterally , and detection of RI of renal artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
doppler for renal artery
Time Frame: 1 year
resistive index of renal artery
1 year

Collaborators and Investigators

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

Sponsor

Sohag 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 (Actual)

October 1, 2024

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-09-07MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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