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

NCT07348484 | Not Yet Recruiting

• 1 other identifier: PI25/00053
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

SGLT2 inhibitors; empagliflozin; urinary biomarker

Outcome Measures

Primary Outcomes (1)

• Change in urinary biomarker panel expression (proteomic fingerprint)

  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.

  Baseline, 6 months, 12 months

Secondary Outcomes (13)

• Change in estimated glomerular filtration rate (eGFR)

  Baseline, 6 months, 12 months

• Histopathological improvement of renal tissue (animal study)

  Monthly up to 9 months

• Monitoring of adverse events of empagliflozin in CKD patients without diabetes

  From baseline to 12 months

• Change in estimated glomerular filtration rate (eGFR)

  From baseline to 12 months

• Change in serum creatinine

  From baselinte to 12 months

Study Arms (2)

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.

Drug: Empagliflozin

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).

Interventions

Empagliflozin DRUG

Oral empagliflozin (10-25 mg daily) for 12 months

Empagliflozin Treatment Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with chronic kidney disease (CKD) stages 2-4.

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead

Study Sites (1)

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine and plasma samples from patients included in the study, all of which will have chronic kidney disease and will be under treatment with empagliflozin.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Martínez Salgado, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

• Pilar Fraile Gómez, MD, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Martínez Salgado, PhD

CONTACT

+34616129633; carlosms@usal.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available starting 12 months after publication of primary results and for a minimum of 5 years thereafter.
• Access Criteria: Qualified researchers with a methodologically sound proposal, as determined by the study steering committee, will be able to access the data. Requests should be directed to the study PI. A data access agreement will be required.

Locations

ES (1)