NCT06631404

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

October 7, 2024

Last Update Submit

October 7, 2024

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • doppler for renal artery

    resistive index of renal artery

    1 year

Study Arms (2)

group SLE

Patients with SLE

Diagnostic Test: renal doppler

group control

matched healthy subjects

Diagnostic Test: renal doppler

Interventions

renal dopplerDIAGNOSTIC_TEST

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

group SLEgroup control

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 35932197BACKGROUND

  • 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.

    PMID: 36407159BACKGROUND

  • 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.

    PMID: 31974366BACKGROUND

  • 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.

    PMID: 35589256BACKGROUND

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

Central Study Contacts

Doaa R Abdelkarim, resident

CONTACT

01027673294doaa_rabea_post@med.sohag.edu.eg

Esam M Abualfadl, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at rheumatology and rehabilitation department

Study Record Dates

First Submitted

October 7, 2024

First Posted

October 8, 2024

Study Start

October 1, 2024

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations

EG(1)