Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis
NCT07493655
Autoimmune Diseases, Connective Tissue Diseases
São Luís, Maranhão, Brazil
View Trial DetailsNCT Number: NCT07780045
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 6 months, and 12 months
Association between SII and SIRI levels and renal function parameters including serum creatinine, eGFR, and proteinuria.
Time frame: 12 months
Ability of baseline and follow-up SII and SIRI values to predict the occurrence of renal flares
Time frame: 12 months
Relationship between SII and SIRI levels and short-term clinical outcomes including renal remission or disease progression.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Emerging Inflammatory Biomarkers (SII and SIRI) for Predicting Disease Activity, Renal Flares and Outcomes in Lupus Nephritis: A Prospective Observational Study
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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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