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

NCT ID: NCT06631404

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lupus Nephritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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group SLE

Patients with SLE

renal doppler

Intervention Type DIAGNOSTIC_TEST

doppler srudy on renal arteries bilaterally , and detection of RI of renal artery

group control

matched healthy subjects

renal doppler

Intervention Type DIAGNOSTIC_TEST

doppler srudy on renal arteries bilaterally , and detection of RI of renal artery

Interventions

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renal doppler

doppler srudy on renal arteries bilaterally , and detection of RI of renal artery

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Rabea Abdelkarim

resident at rheumatology and rehabilitation department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Doaa R Abdelkarim, resident

Role: CONTACT

01027673294

Esam M Abualfadl, professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 35932197 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36407159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31974366 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35589256 (View on PubMed)

Other Identifiers

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Soh-Med-24-09-07MS

Identifier Type: -

Identifier Source: org_study_id

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