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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorInstituto de Investigación Biomédica de Salamanca

About this trial

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

Qualifiers

≥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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Empagliflozin

Treatment groups

300 Participants
are divided into 2 treatment groups