Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Condition(s) studied
Investigational drug(s) / intervention(s)
Empagliflozin: Oral empagliflozin (10-25 mg daily) for 12 months
Study summary
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.
Eligibility
Primary outcome measure(s)
- Change in urinary biomarker panel expression (proteomic fingerprint) — Baseline, 6 months, 12 months
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Universitario de Salamanca | Salamanca | Spain |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07348484 on ClinicalTrials.gov ↗ ← All trials in Spain