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

NCT ID: NCT07348484

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-03-31

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.

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.

Conditions

Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Empagliflozin

Intervention Type: DRUG

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

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).

No interventions assigned to this group

Interventions

Empagliflozin

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Martínez Salgado, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Pilar Fraile Gómez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

Hospital Universitario de Salamanca

Salamanca, , Spain

Countries

Spain

Central Contacts

Carlos Martínez Salgado, PhD

Role: CONTACT

carlosms@usal.es

+34616129633

Facility Contacts

Carlos Martínez Salgado, PhD

Role: primary

carlosms@usal.es

+34616129633

Pilar Fraile Gómez, MD, PhD

Role: backup

pilarfg@usal.es

+34923291100

Other Identifiers

PI25/00053

Identifier Type: -

Identifier Source: org_study_id