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Lupus NephritisNCT07780045

SII and SIRI as Prognostic Biomarkers in Lupus Nephritis

An observational study of Lupus Nephritis and Systemic Lupus Erythematosus, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective observational study aims to evaluate the prognostic utility of the Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) as novel inflammatory biomarkers for monitoring disease activity and predicting renal progression, flares, and outcomes in patients with lupus… Read more about this study

Who is it for?
Ages 18 to 70 years
How many people
100 participants
Where
No sites listed yet
Study dates
19 Aug 2026to 19 Oct 2027
How long will I take part?
12 Months
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults with lupus nephritis attending the Internal Medicine Department (Nephrology and Rheumatology units) at Assiut University Hospitals who meet the study eligibility criteria.

Who may be able to join

  • Age ≥ 18 years
  • Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria
  • Confirmed lupus nephritis according to ISN/RPS classification

Who cannot join

  • Active infection, sepsis, or other concurrent inflammatory or autoimmune conditions
  • Malignancy or hematologic disorders affecting blood cell counts
  • Pregnancy
  • Use of medications significantly affecting blood counts (such as recent chemotherapy or G-CSF)
  • Incomplete medical records or anticipated loss to follow-up

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Abobakr A bakr, Resident contact

01100440065 ext. 01100440065

AbuBakr.18313431@med.aun.edu.eg

About this study

Official title: Emerging Inflammatory Biomarkers (SII and SIRI) for Predicting Disease Activity, Renal Flares and Outcomes in Lupus Nephritis: A Prospective Observational Study

This prospective observational study aims to evaluate the prognostic utility of the Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) as novel inflammatory biomarkers for monitoring disease activity and predicting renal progression, flares, and outcomes in patients with lupus nephritis.

Read the detailed description

Lupus nephritis (LN) is a common and serious manifestation of systemic lupus erythematosus (SLE) that can lead to progressive renal damage and end-stage renal disease. Current assessment of disease activity and prognosis relies mainly on proteinuria, serum creatinine, estimated glomerular filtration rate (eGFR), and kidney biopsy, which is invasive and not always feasible for repeated monitoring.

Simple blood count-derived inflammatory indices, such as the Systemic Immune-Inflammation Index (SII) and the Systemic Inflammation Response Index (SIRI), have recently emerged as potential biomarkers of systemic inflammation. These indices are inexpensive, readily available, and may reflect disease activity and renal risk in lupus nephritis. However, their prognostic value remains incompletely established, particularly in prospective settings.

This prospective observational study will evaluate the ability of SII and SIRI to monitor disease activity and predict renal flares and outcomes in patients with lupus nephritis over a 12-month follow-up period.

Keywords
Systemic Immune-Inflammation Index SII, Systemic Inflammation Response Index SIRI, Lupus Nephritis Biomarkers
Medical subject headings
Lupus Nephritis, Lupus Erythematosus, Systemic, Kidney Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of SII and SIRI with disease activity

    Correlation between Systemic Immune-Inflammation Index (SII) and Systemic Inflammation Response Index (SIRI) levels with disease activity assessed by SLEDAI-2K and Renal SLEDAI scores.

    Measured: Baseline, 6 months, and 12 months

Secondary outcomes (3)

  1. Association of SII and SIRI with renal function parameters

    Association between SII and SIRI levels and renal function parameters including serum creatinine, eGFR, and proteinuria.

    Measured: Baseline, 6 months, and 12 months

  2. Predictive value of SII and SIRI for renal flares

    Ability of baseline and follow-up SII and SIRI values to predict the occurrence of renal flares

    Measured: 12 months

  3. Association of SII and SIRI with clinical outcomes

    Relationship between SII and SIRI levels and short-term clinical outcomes including renal remission or disease progression.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start19 Aug 2026 (estimated)
  3. Primary completion19 Aug 2027 (estimated)
  4. Study completion19 Oct 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780045
Sponsor's protocol ID
Lupus-Nephritis-SII-SIRI
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
24 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang DC, Xu WD, Wang SN, Wang X, Leng W, Fu L, Liu XY, Qin Z, Huang AF. Lupus nephritis or not? A simple and clinically friendly machine learning pipeline to help diagnosis of lupus nephritis. Inflamm Res. 2023 Jun;72(6):1315-1324. doi: 10.1007/s00011-023-01755-7. Epub 2023 Jun 10.

    PubMed 37300586

  • Zhang X, Chen Y, Fan Y, Gao D, Zhang Z. NLR (neutrophil to lymphocyte ratio), PLR (platelet to lymphocyte ratio), and SII (systemic immune-inflammation index) reflect disease activity and renal remission in patients with lupus nephritis. Front Immunol. 2025 Sep 30;16:1646276. doi: 10.3389/fimmu.2025.1646276. eCollection 2025.

    PubMed 41098718

  • Yang CH, Wang XY, Zhang YH, Ding N. SIRI and SII as potential biomarkers of disease activity and lupus nephritis in systemic lupus erythematosus. Front Immunol. 2025 Jan 31;16:1530534. doi: 10.3389/fimmu.2025.1530534. eCollection 2025.

    PubMed 39958362

  • Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.

    PubMed 11838846

Questions about this trial

What is this clinical trial studying?

An observational study of Lupus Nephritis and Systemic Lupus Erythematosus, run by Assiut University.

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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Abobakr A bakr, Resident (01100440065 ext. 01100440065, AbuBakr.18313431@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of SII and SIRI with disease activity (time frame: Baseline, 6 months, and 12 months). 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 NCT07780045, 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 24 Aug 2026.

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