SII and SIRI as Prognostic Biomarkers in Lupus Nephritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria
Confirmed lupus nephritis according to ISN/RPS classification
Disqualifiers
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)
Trial population
Adults with lupus nephritis attending the Internal Medicine Department (Nephrology and Rheumatology units) at Assiut University Hospitals who meet the study eligibility criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, 6 months, and 12 monthsSecondary outcomes
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.
Time frame
Baseline, 6 months, and 12 months2
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 months3
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: