This prospective observational study aims to assess the association between real-world use of sodium-glucose co-transporter 2 inhibitors (SGLT2i; e.g., empagliflozin, dapagliflozin) and renal function decline in adults with chronic kidney disease (CKD) stages 2-4 (KDIGO classification). The study will also validate a urinary biomarker panel for early diagnosis and monitoring of CKD progression.
No investigational product is assigned, and medical practice or prescription patterns are not altered.
≥18 years old
Diagnosed with chronic kidney disease (KDIGO stages 2-4)
Life expectancy ≥12 months
Available clinical and laboratory data in the electronic medical record
Current or recent renal replacement therapy or kidney transplantation
End-stage renal disease
Participation in interventional trials that may affect outcomes
Allergy or intolerance to SGLT2i (for exposed cohort)
Participants with chronic kidney disease (CKD) stages 2-4.
Cohort
Prospective
Empagliflozin
DrugOral empagliflozin (10-25 mg daily) for 12 months
Change in urinary biomarker panel expression (proteomic fingerprint)
Quantitative assessment of urinary biomarkers (including KIM-1, transferrin, IGFBP7, TIMP-2, among others) to evaluate disease progression and treatment response. Urinary biomarkers will be assessed using liquid chromatography-mass spectrometry (LC-MS/MS)-based differential proteomic analysis. Biomarker expression will be quantified as log2 fold change with false discovery rate (FDR) correction. Selected biomarkers will be validated using enzyme-linked immunosorbent assay (ELISA) or equivalent immunoassays. Biomarker concentrations will be normalized to urinary creatinine levels.
Change in estimated glomerular filtration rate (eGFR)
Evaluation of renal function improvement or stabilization during SGLT2 inhibitor treatment.
Histopathological improvement of renal tissue (animal study)
Monthly analysis of renal fibrosis, inflammation, and extracellular matrix accumulation in preclinical models treated with empagliflozin.
Monitoring of adverse events of empagliflozin in CKD patients without diabetes
Adverse events (AEs) will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE, latest version), including severity grading and assessment of causality related to treatment. Serious adverse events (SAEs) and discontinuations due to AEs will be specifically tracked by the investigator.
Change in estimated glomerular filtration rate (eGFR)
Change in renal function assessed by estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation during empagliflozin treatment using the Serum creatinine-based CKD-EPI equation.
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