Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin
Overview
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:
1. validation of a urinary biomarker panel obtained through differential proteomics for early detection and monitoring of CKD progression, and 2. 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.
Interventions
- Drug Empagliflozin
Oral empagliflozin (10-25 mg daily) for 12 months
Primary outcome measures
- Change in urinary biomarker panel expression (proteomic fingerprint) [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Universitario de Salamanca — Salamanca
Identifiers
NCT: NCT07348484 · PI25/00053