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Starting soon Observational

Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors

NCT07348484 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2026-01
Last updated
2026-01-16

Condition(s) studied

Chronic Kidney Disease

Investigational drug(s) / intervention(s)

Empagliflozin →

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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * ≥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 Exclusion Criteria: * 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)

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)

FacilityCityRegionStatus
Hospital Universitario de Salamanca Salamanca Spain
Official registry record

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