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

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: Lupus Nephritis
• Intervention / Treatment: Diagnostic test: renal doppler

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Doaa R Abdelkarim, resident; Phone Number: 01027673294; Email: doaa_rabea_post@med.sohag.edu.eg
• 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

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

How is the study designed?

Number of groups / cohorts

2

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	resistive index of renal artery	1 year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Alforaih N, Whittall-Garcia L, Touma Z. A Review of Lupus Nephritis. J Appl Lab Med. 2022 Oct 29;7(6):1450-1467. doi: 10.1093/jalm/jfac036.
• Ameer MA, Chaudhry H, Mushtaq J, Khan OS, Babar M, Hashim T, Zeb S, Tariq MA, Patlolla SR, Ali J, Hashim SN, Hashim S. An Overview of Systemic Lupus Erythematosus (SLE) Pathogenesis, Classification, and Management. Cureus. 2022 Oct 15;14(10):e30330. doi: 10.7759/cureus.30330. eCollection 2022 Oct.
• Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. doi: 10.1038/s41572-019-0141-9.
• Anstee QM, Castera L, Loomba R. Impact of non-invasive biomarkers on hepatology practice: Past, present and future. J Hepatol. 2022 Jun;76(6):1362-1378. doi: 10.1016/j.jhep.2022.03.026.

Study record dates

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: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Lupus Nephritis
• 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