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NCT Number: NCT07017868

Correlation Between Serum Uric Acid, Serum Homocysteine Level and Interleukin- 17 in Lupus Nephritis Patients

Systemic lupus erythematosus (SLE) is a chronic inflammatory multisystem autoimmune disease characterized by pathogenic autoantibodies production against nuclear structures . SLE affecting mainly women of childbearing age and is characterized by unpredictable flares and remissions. Disease severity varied from a mild episodic disorder to a rapidly progressive life-threatening illness. The kidney is the most commonly involved visceral organ in SLE. Therefore, identifying new noninvasive biomarkers of LN severity and outcome is mandatory. IL-17 is a potent pro-infammatory cytokine that amplifes T-cell activation and stimulates fibroblast cells, endothelial, and epithelial cells to produce several pro-infammatory mediators, including IL-1β, IL-6, and TNF-α. IL-17 receptor signaling enhances the expression of multiple pro-infammatory mediators. Hence, IL-17 enhances the production of neutrophil-attracting chemokines

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

magdy M Amin, professor

CONTACT

About this study

Systemic lupus erythematosus (SLE) is a chronic inflammatory multisystem autoimmune disease characterized by pathogenic autoantibodies production against nuclear structures. SLE affecting mainly women of childbearing age and is characterized by unpredictable flares and remissions. Disease severity varied from a mild episodic disorder to a rapidly progressive life-threatening illness. The kidney is the most commonly involved visceral organ in SLE Lupus nephritis (LN) is one of the most serious manifestations of SLE since it is associated with significant morbidity and mortality and affects up to 60% of SLE patients. Nephritic syndrome and acute kidney injuries can complicate LN and increase the risk of end stage renal disease (ESRD) . Early diagnosis of renal involvement in SLE patients is important to improve the long-term outcome and increase the survival rate .

LN is diagnosed by either the presence of proteinuria (>0.5 g/day), active urinary sediment (with red blood cell, granular, tubular and/or mixed casts), or an unexplained rise in serum creatinine. A renal biopsy is known to be the gold standard for the diagnosis of LN because it gives information and details about the pattern and severity of kidney affection as well as the exclusion of other mimics of LN . Each of these factors weighs heavily on treatment choices. However, kidney biopsy is an invasive technique, and it is contraindicated in some situations such as bleeding and infection, associated with renal biopsy .

Therefore, identifying new noninvasive biomarkers of LN severity and outcome is mandatory. IL-17 is a potent pro-infammatory cytokine that amplifes T-cell activation and stimulates fibroblast cells, endothelial, and epithelial cells to produce several pro-infammatory mediators, including IL-1β, IL-6, and TNF-α. IL-17 receptor signaling enhances the expression of multiple pro-infammatory mediators. Hence, IL-17 enhances the production of neutrophil-attracting chemokines .

Few studies focused on the importance of IL-17 in SLE, particularly LN, and its relation to different disease activity parameters, so we aimed to explore its relation with uric acid and homocysteine in LN.

Also, Lupus nephritis (LN) is closely associated with hyperuricemia, and uric acid is the metabolite of purine that is excreted mainly in urine and considered a risk factor for renal involvement in systemic lupus erythematosus (SLE).

We postulated that patients with lupus nephritis are more likely to have elevated homocysteine levels. Homocysteine is metabolized by two alternative pathways, including its remethylation and transsulfuration. Elevated serum homocysteine can occur in 5 to 10 percent of the population. Increased serum homocysteine levels are seen in approximately 15% of patients with systemic lupus erythematosus.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Patients receive any hyperuricemia treatment
  • Pregnancy
  • Malignancy
  • Diabetes.
  • Hypertension.
  • Heart failure.
  • Hepatic diseases.
  • Chronic renal failure other than lupus nephritis.
  • Renal artery stenosis.
  • Renal vein thrombosis.
  • Intrarenal arteriovenous fistula.
  • Obstructive nephropathy.
  • Urinary tract obstruction that could affect RI of intra renal arteries.
  • Uncooperative patients.
  • Patients not able and willing to give written informed consent.

Treatment and study plan

interleukin- 17

Diagnostic Test

focused on the importance of IL-17 in SLE, and its relation to different disease activity

Primary outcomes

  1. SLE disease activity index (SLEDAI) will be assessed

    Time frame: 1 year

    . IL-17 is a potent pro-infammatory cytokine that amplifes T-cell activation and stimulates fibroblast cells, endothelial, and epithelial cells to produce several pro-infammatory mediators, including IL-1β, IL-6, and TNF-α. IL-17 receptor signaling enhances the expression of multiple pro-infammatory mediators

Study contacts

Contact information is provided by the study sponsor or research team.

Sara M Ahmed, resident

CONTACT

[email protected]

01099676623

abdelhady R Abdel-Gawad, MD

CONTACT

01006955537

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.