SII and SIRI as Prognostic Biomarkers in Lupus Nephritis

N/ANot Yet RecruitingNCT07780045

Assiut University100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Lupus Nephritis Systemic Lupus Erythematosus Kidney Diseases

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 6 months, and 12 months

Secondary Outcomes

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.

Time frame: Baseline, 6 months, and 12 months

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

Time frame: 12 months

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.

Time frame: 12 months

Central Contacts

Abobakr A bakr, Resident

CONTACT

01100440065 AbuBakr.18313431@med.aun.edu.eg

Data from ClinicalTrials.gov

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