Urinary biomarker test and real-world use of SGLT2 inhibitors in CKD
Official title: Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin
Run by Instituto de Investigación Biomédica de Salamanca · NCT07348484 · Data updated 2026-11-12
This study tests whether SGLT2 inhibitors used in routine care help slow kidney function decline in adults with CKD and whether a urinary biomarker panel can detect and monitor progression.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Instituto de Investigación Biomédica de Salamanca Academic / other |
| Locations | 1 site (Salamanca) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | April 2028 |
| Study ends | December 2028 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07348484 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with CKD stages 2–4 who have electronic medical records with sufficient clinical data and are either starting an SGLT2 inhibitor or matched non-users.
✕Probably not a fit
Patients who do not start an SGLT2 inhibitor or who have advanced kidney disease not represented by CKD stages 2–4 may see no benefit in this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, real-world observational study in adults with CKD stages 2–4. It follows patients who start an SGLT2 inhibitor (empagliflozin) and matched controls over 12 months, using electronic health records and lab data. The study also aims to validate a urinary biomarker panel for early CKD detection and progression monitoring. No new treatments are assigned by the study; it observes real-world practice and outcomes. Primary outcome is the annual rate of eGFR decline, with secondary outcomes including major renal events, cardiovascular hospitalizations, mortality, and adverse drug reactions, plus exploratory links between biomarkers and outcomes.
Why it matters
Potential benefit: If successful, patients could benefit from better guidance on SGLT2 inhibitor use in CKD and a validated urinary biomarker panel to monitor disease.
How similar studies have gone: Previous real-world studies have shown signals of SGLT2 inhibitors slowing CKD progression; how this translates with a urinary biomarker panel is exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Hospital Universitario de Salamanca
Salamanca, Spain Recruiting
Study contacts
- Principal investigator: Carlos Martínez Salgado, PhD — University of Salamanca
- Study coordinator: Carlos Martínez Salgado, PhD
- Email: carlosms@usal.es
- Phone: +34616129633
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.