Homocysteine Level and Interleukin- 17 in Lupus Nephritis PatientsNCT07017868
Correlation Between Serum Uric Acid, Serum Homocysteine Level and Interleukin- 17 in Lupus Nephritis Patients
An observational study of Homocysteine Level and Interleukin- 17 in Lupus Nephritis Patients, run by Sohag University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Homocysteine Level and Interleukin- 17 in Lupus Nephritis Patients
- What is being tested?
- interleukin- 17
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include 80 established SLE patients who will be recruited from Rheumatology and Rehabilitation department at Sohag university hospital,40 of them with nephritis and other 40 witout nephritis, in addition to 40 control who will be matched for sex, age, and level of schooling without history of any systemic active disease (healthy people).
Who may be able to join
- ● 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
Who cannot join
- ● Individuals with other autoimmune diseases.
- Patients receive any hyperuricemia treatment
- Pregnancy
- Malignancy
- Diabetes.
- Hypertension.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
abdelhady R Abdel-Gawad, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
magdy M Amin, professor
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. 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
Read the detailed description
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.
- Being tested
- interleukin- 17
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin- 17Diagnostic test
focused on the importance of IL-17 in SLE, and its relation to different disease activity
| Study group | Role | What they receive |
|---|---|---|
| CASE 1 | Patient with systemic lupus witout nephritis Receives: Diagnostic Test: interleukin- 17 | |
| case 2 | Patient with systemic lupus with nephritis Receives: Diagnostic Test: interleukin- 17 | |
| controls | healthy people Receives: Diagnostic Test: interleukin- 17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLE disease activity index (SLEDAI) will be assessed
. 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jan 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Homocysteine Level and Interleukin- 17 in Lupus Nephritis PatientsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017868
- Sponsor's protocol ID
- Soh-Med--25-4-07MS
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35932197Zhu S, Qian Y. IL-17/IL-17 receptor system in autoimmune disease: mechanisms and therapeutic potential. Clin Sci (Lond). 2012 Jun;122(11):487-511. doi: 10.1042/CS20110496.
PubMed 22324470Ameer 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.
PubMed 36407159Anstee 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.
PubMed 35589256
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Uric Acid, Serum Homocysteine Level and Interleukin- 17 in Lupus Nephritis Patients
- ClinicalTrials.gov ID
- NCT07017868
- Acronym / sponsor ID
- Soh-Med--25-4-07MS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CASE 1 | – | Diagnostic Test: interleukin- 17Patient with systemic lupus witout nephritis |
| case 2 | – | Diagnostic Test: interleukin- 17Patient with systemic lupus with nephritis |
| controls | – | Diagnostic Test: interleukin- 17healthy people |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include 80 established SLE patients who will be recruited from Rheumatology and Rehabilitation department at Sohag university hospital,40 of them with nephritis and other 40 witout nephritis, in addition to 40 control who will be matched for sex, age, and level of schooling without history of any systemic active disease (healthy people).
Key inclusion criteria (4 listed)
- ● Aged ≥18 years.
Key exclusion criteria (16 listed)
- ● Individuals with other autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interleukin- 17focused on the importance of IL-17 in SLE, and its relation to different disease activity | Diagnostic test | CASE 1, case 2, controls |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Background: PubMed 35932197Alforaih 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.
- Background: PubMed 22324470Zhu S, Qian Y. IL-17/IL-17 receptor system in autoimmune disease: mechanisms and therapeutic potential. Clin Sci (Lond). 2012 Jun;122(11):487-511. doi: 10.1042/CS20110496.
- Background: PubMed 36407159Ameer 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.
- Background: PubMed 35589256Anstee 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
abdelhady R Abdel-Gawad, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Homocysteine Level and Interleukin- 17 in Lupus Nephritis Patients, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M Ahmed, resident (01099676623, sara_abdelrahim_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLE disease activity index (SLEDAI) will be assessed (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07017868, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.