[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619735":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":30,"locations":35,"responsibleParty":52,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":10,"enrollmentInfo":63,"targetDuration":66,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Instituto de Investigación Biomédica de Salamanca","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Empagliflozin Treatment Group",null,"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.",[13],"Drug: Empagliflozin",{"label":15,"type":10,"description":16,"interventionNames":10},"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.\n\nThese patients receive standard clinical care according to local and national guidelines.\n\nThey are followed on the same schedule (baseline, 6, and 12 months) and have identical variables collected from electronic health records and laboratory systems.\n\nReasons for non-initiation of SGLT2i are documented systematically and may include:\n\nNot meeting indication criteria established by the Spanish National Health System (e.g., albumin-to-creatinine ratio \\\u003C200 mg\u002Fg, eGFR \\\u003C20 mL\u002Fmin\u002F1.73 m² for empagliflozin or \\\u003C25 for dapagliflozin), or\n\nClinical contraindications or conditions such as significant hypovolemia or hypotension, recurrent urinary or genital infections, or hypersensitivity.\n\nControl patients will be censored in the primary analysis if they later start SGLT2i therapy (cross-over).",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"DRUG","Empagliflozin","Oral empagliflozin (10-25 mg daily) for 12 months",[9],[24,28],{"name":25,"affiliation":26,"role":27},"Carlos Martínez Salgado, PhD","University of Salamanca","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":26,"role":27},"Pilar Fraile Gómez, MD, PhD",[31],{"name":25,"role":32,"phone":33,"phoneExt":10,"email":34},"CONTACT","+34616129633","carlosms@usal.es",[36],{"facility":37,"status":10,"city":38,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hospital Universitario de Salamanca","Salamanca","Spain","ES",{"type":42,"coordinates":43},"Point",[44,45],-3.67975,40.42972,{"lat":45,"lon":44},[48,49],{"name":25,"role":32,"phone":33,"phoneExt":10,"email":34},{"name":29,"role":32,"phone":50,"phoneExt":10,"email":51},"+34923291100","pilarfg@usal.es",{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100619735","urinary-biomarker-based-diagnostic-and-monitoring-system-for-chronic-kidney-disease-and-real-world-effectiveness-of-sglt2-inhibitors-100619735",false,"NCT07348484","Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors","Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin","Inclusion Criteria:\n\n* ≥18 years old\n* Diagnosed with chronic kidney disease (KDIGO stages 2-4)\n* Life expectancy ≥12 months\n* Available clinical and laboratory data in the electronic medical record\n\nExclusion Criteria:\n\n* Current or recent renal replacement therapy or kidney transplantation\n* End-stage renal disease\n* Participation in interventional trials that may affect outcomes\n* Allergy or intolerance to SGLT2i (for exposed cohort)","ALL","16 Years",{"count":64,"type":65},300,"ESTIMATED","1 Year","OBSERVATIONAL","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.\n\nNo investigational product is assigned, and medical practice or prescription patterns are not altered.",[70],"Chronic Kidney Disease",[72,73,74],"SGLT2 inhibitors","empagliflozin","urinary biomarker","NOT_YET_RECRUITING","2026-01-12",{"date":78,"type":79},"2026-01-16","ACTUAL",{"date":81,"type":65},"2026-01",{"date":83,"type":65},"2028-03",{"name":5,"class":6},1]