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

Sponsor
Instituto de Investigación Biomédica de Salamanca
Study ID
NCT07348484
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Oral empagliflozin (10-25 mg daily) for 12 months

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Empagliflozin Treatment Group
    Participants with chronic kidney disease (CKD) stages 2-4 will receive oral empagliflozin (10-25 mg daily) for 12 months. Urinary and plasma samples will be collected at baseline, 6 months, and 12 months to evaluate the urinary biomarker panel, renal function (eGFR), and treatment safety.
  • Arm: Control group
    Adults with chronic kidney disease (CKD) stages 2-4 (KDIGO classification) managed in nephrology outpatient clinics without initiation of SGLT2 inhibitors at baseline or during follow-up. These patients receive standard clinical care according to local and national guidelines. They are followed on the same schedule (baseline, 6, and 12 months) and have identical variables collected from electronic health records and laboratory systems. Reasons for non-initiation of SGLT2i are documented systematically and may include: Not meeting indication criteria established by the Spanish National Health System (e.g., albumin-to-creatinine ratio \<200 mg/g, eGFR \<20 mL/min/1.73 m² for empagliflozin or \<25 for dapagliflozin), or Clinical contraindications or conditions such as significant hypovolemia or hypotension, recurrent urinary or genital infections, or hypersensitivity. Control patients will be censored in the primary analysis if they later start SGLT2i therapy (cross-over).

Primary Outcome Measure

Change in urinary biomarker panel expression (proteomic fingerprint) [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts

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