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NCT Number: NCT07348484

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

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.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This is a real-world, observational study with prospective follow-up and retrospective baseline data when available, conducted at the Nephrology Department of the University Hospital of Salamanca, Spain.

The project integrates translational and clinical components:

  • validation of a urinary biomarker panel obtained through differential proteomics for early detection and monitoring of CKD progression, and
  • evaluation of the effectiveness and safety of SGLT2i in routine clinical practice.

A total of 300 adults with CKD stages 2-4 will be included (150 initiating SGLT2i and 150 matched controls). Participants will be followed for 12 months (baseline, 6, and 12 months). Data will be extracted exclusively from electronic health records and laboratory systems.

The primary outcome is the annual decline rate of estimated glomerular filtration rate (eGFR, CKD-EPI 2021). Secondary outcomes include a composite renal endpoint (≥40% sustained eGFR decline, renal replacement therapy, transplantation, or renal death), cardiovascular hospitalization, all-cause mortality, adverse drug reactions (ADRs), and real-world patterns of SGLT2i use.

Exploratory analyses will assess associations between urinary biomarkers and clinical outcomes.

The study follows Spanish regulations for observational studies with medicinal products (Real Decreto 957/2020), with ethics approval and informed consent for biological samples.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Empagliflozin

Drug

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

Primary outcomes

  1. Change in urinary biomarker panel expression (proteomic fingerprint)

    Time frame: Baseline, 6 months, 12 months

    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.

Secondary outcomes

  1. Change in estimated glomerular filtration rate (eGFR)

    Time frame: Baseline, 6 months, 12 months

    Evaluation of renal function improvement or stabilization during SGLT2 inhibitor treatment.

  2. Histopathological improvement of renal tissue (animal study)

    Time frame: Monthly up to 9 months

    Monthly analysis of renal fibrosis, inflammation, and extracellular matrix accumulation in preclinical models treated with empagliflozin.

  3. Monitoring of adverse events of empagliflozin in CKD patients without diabetes

    Time frame: From baseline to 12 months

    Adverse events (AEs) will be recorded and classified according to Common Terminology Criteria for Adverse Events (CTCAE, latest version), including severity grading and assessment of causality related to treatment.

    Serious adverse events (SAEs) and discontinuations due to AEs will be specifically tracked by the investigator.

  4. Change in estimated glomerular filtration rate (eGFR)

    Time frame: From baseline to 12 months

    Change in renal function assessed by estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation during empagliflozin treatment using the Serum creatinine-based CKD-EPI equation.

  5. Change in serum creatinine

    Time frame: From baselinte to 12 months

    hange in serum creatinine levels to assess renal safety during treatment with empagliflozin by standard clinical laboratory assay (mg/dL).

  6. Change in urinary albumin-to-creatinine ratio

    Time frame: From baseline to 12 months

    Change in urinary albumin-to-creatinine ratio as a marker of renal damage and safety during empagliflozin treatment by standard urine laboratory testing (mg/g creatinine).

  7. Change in serum electrolyte levels

    Time frame: From baseline to 12 months

    Change in serum sodium and potassium levels to evaluate electrolyte safety during empagliflozin treatment by standard clinical laboratory testing (mmol/L).

  8. Change in liver function tests

    Time frame: From baseline to 12 months

    Change in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to assess hepatic safety by standard clinical laboratory assays (U/L).

  9. Change in glycated hemoglobin (HbA1c)

    Time frame: From baseline to 12 months.

    Change in HbA1c levels to monitor metabolic safety in non-diabetic CKD patients treated with empagliflozin by standard laboratory assay (%).

  10. Change in hematological parameters

    Time frame: From baseline to 12 months

    Change in complete blood count parameters to evaluate hematological safety during treatment by standard clinical laboratory testing.

  11. Change in blood pressure

    Time frame: From baseline to 12 months

    Assessment of changes in both blood pressures (systolic and diastolic), by Standard sphygmomanometer measurement (mmHg).

  12. Change in body weight

    Time frame: From baseline to 12 months

    Change in body weight to assess tolerability and volume status during empagliflozin treatment by calibrated clinical scale (kg).

  13. Discontinuation due to treatment intolerance

    Time frame: From baseline to 12 months

    Number and proportion of participants who permanently discontinue empagliflozin due to treatment-related intolerance or adverse events. It will be achieved trough clinical visit records and adverse event reporting.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos Martínez Salgado, PhD

CONTACT

[email protected]

+34616129633

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Biomédica de Salamanca

Other

Registry information

Official study title

Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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