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NCT Number: NCT07780045

SII and SIRI as Prognostic Biomarkers in Lupus Nephritis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Correlation of SII and SIRI with disease activity

    Time frame: Baseline, 6 months, and 12 months

    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.

Secondary outcomes

  1. Association of SII and SIRI with renal function parameters

    Time frame: Baseline, 6 months, and 12 months

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

  2. Predictive value of SII and SIRI for renal flares

    Time frame: 12 months

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

  3. Association of SII and SIRI with clinical outcomes

    Time frame: 12 months

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

Study contacts

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

Abobakr A bakr, Resident

CONTACT

[email protected]

01100440065 ext. 01100440065

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 24, 2026

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.

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