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

Sex: All

Ages: 16 Years – N/A

Healthy volunteers: No

Enrollment: 300

Sponsor: Instituto de Investigación Biomédica de Salamanca

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 Criteria

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)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07348484). StuddyBuddy aggregates publicly available trial information.