Chronic Kidney DiseaseNCT07348484
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
An observational study of Chronic Kidney Disease, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with chronic kidney disease (CKD) stages 2-4.
Who may be able to join
- ≥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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Salamanca
Salamanca
Carlos Martínez Salgado, PhD, +34616129633, carlosms@usal.es
Pilar Fraile Gómez, MD, PhD, +34923291100, pilarfg@usal.es
About this study
Official title: Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Empagliflozin
- Keywords
- SGLT2 inhibitors, empagliflozin, urinary biomarker
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Oral empagliflozin (10-25 mg daily) for 12 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (13)
Change in estimated glomerular filtration rate (eGFR)
Evaluation of renal function improvement or stabilization during SGLT2 inhibitor treatment.
Measured: Baseline, 6 months, 12 months
Histopathological improvement of renal tissue (animal study)
Monthly analysis of renal fibrosis, inflammation, and extracellular matrix accumulation in preclinical models treated with empagliflozin.
Measured: Monthly up to 9 months
Monitoring of adverse events of empagliflozin in CKD patients without diabetes
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.
Measured: From baseline to 12 months
Change in estimated glomerular filtration rate (eGFR)
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.
Measured: From baseline to 12 months
Change in serum creatinine
hange in serum creatinine levels to assess renal safety during treatment with empagliflozin by standard clinical laboratory assay (mg/dL).
Measured: From baselinte to 12 months
Change in urinary albumin-to-creatinine ratio
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).
Measured: From baseline to 12 months
Change in serum electrolyte levels
Change in serum sodium and potassium levels to evaluate electrolyte safety during empagliflozin treatment by standard clinical laboratory testing (mmol/L).
Measured: From baseline to 12 months
Change in liver function tests
Change in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels to assess hepatic safety by standard clinical laboratory assays (U/L).
Measured: From baseline to 12 months
Change in glycated hemoglobin (HbA1c)
Change in HbA1c levels to monitor metabolic safety in non-diabetic CKD patients treated with empagliflozin by standard laboratory assay (%).
Measured: From baseline to 12 months.
Change in hematological parameters
Change in complete blood count parameters to evaluate hematological safety during treatment by standard clinical laboratory testing.
Measured: From baseline to 12 months
Change in blood pressure
Assessment of changes in both blood pressures (systolic and diastolic), by Standard sphygmomanometer measurement (mmHg).
Measured: From baseline to 12 months
Change in body weight
Change in body weight to assess tolerability and volume status during empagliflozin treatment by calibrated clinical scale (kg).
Measured: From baseline to 12 months
Discontinuation due to treatment intolerance
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.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Martínez Salgado, PhD, Principal investigator, University of SalamancaPilar Fraile Gómez, MD, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348484
- Sponsor's protocol ID
- PI25/00053
- Status last verified
- Nov 2026
- First submitted
- 18 Nov 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized datasets and analytic code will be available upon reasonable request, following approval by the Ethics Committee and IBSAL data governance board.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin
- ClinicalTrials.gov ID
- NCT07348484
- Acronym / sponsor ID
- PI25/00053
- Conditions
- Chronic Kidney Disease
- Keywords
- SGLT2 inhibitors, empagliflozin, urinary biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Instituto de Investigación Biomédica de SalamancaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin Treatment Group | – | Drug: EmpagliflozinParticipants 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. |
| 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). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with chronic kidney disease (CKD) stages 2-4.
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinOral empagliflozin (10-25 mg daily) for 12 months | Drug | Empagliflozin Treatment Group |
Primary outcome
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.
13 secondary outcomes
Change in estimated glomerular filtration rate (eGFR)
Time frame: Baseline, 6 months, 12 months
Histopathological improvement of renal tissue (animal study)
Time frame: Monthly up to 9 months
Monitoring of adverse events of empagliflozin in CKD patients without diabetes
Time frame: From baseline to 12 months
Change in estimated glomerular filtration rate (eGFR)
Time frame: From baseline to 12 months
Change in serum creatinine
Time frame: From baselinte to 12 months
Change in urinary albumin-to-creatinine ratio
Time frame: From baseline to 12 months
Change in serum electrolyte levels
Time frame: From baseline to 12 months
Change in liver function tests
Time frame: From baseline to 12 months
Change in glycated hemoglobin (HbA1c)
Time frame: From baseline to 12 months.
Change in hematological parameters
Time frame: From baseline to 12 months
Change in blood pressure
Time frame: From baseline to 12 months
Change in body weight
Time frame: From baseline to 12 months
Discontinuation due to treatment intolerance
Time frame: From baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Anonymized datasets and analytic code will be available upon reasonable request, following approval by the Ethics Committee and IBSAL data governance board.
Related trials for Chronic Kidney Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Martínez Salgado, PhD principal investigator
University of Salamanca
Pilar Fraile Gómez, MD, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Martínez Salgado, PhD (+34616129633, carlosms@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary biomarker panel expression (proteomic fingerprint) (time frame: Baseline, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.