Clinical trial NCT06631404: Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients
Official title: Renal Arterial Resistive Index as a Noninvasive Biomarker of Disease Activity in Lupus Nephritis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Nephritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: doppler for renal artery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.