[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619735":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":60,"studyPopulation":61,"armGroups":62,"interventions":71,"overallOfficials":77,"centralContacts":84,"locations":89,"responsibleParty":106,"collaborators":56,"id":108,"slug":56,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":56,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":56,"enrollmentInfo":116,"targetDuration":119,"studyType":120,"phases":56,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":128,"whyStopped":56,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Instituto de Investigación Biomédica de Salamanca","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002FMS)-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.","Baseline, 6 months, 12 months",[14,17,21,25,27,31,34,37,40,44,47,50,53],{"measure":15,"description":16,"timeFrame":12},"Change in estimated glomerular filtration rate (eGFR)","Evaluation of renal function improvement or stabilization during SGLT2 inhibitor treatment.",{"measure":18,"description":19,"timeFrame":20},"Histopathological improvement of renal tissue (animal study)","Monthly analysis of renal fibrosis, inflammation, and extracellular matrix accumulation in preclinical models treated with empagliflozin.","Monthly up to 9 months",{"measure":22,"description":23,"timeFrame":24},"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.\n\nSerious adverse events (SAEs) and discontinuations due to AEs will be specifically tracked by the investigator.","From baseline to 12 months",{"measure":15,"description":26,"timeFrame":24},"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.",{"measure":28,"description":29,"timeFrame":30},"Change in serum creatinine","hange in serum creatinine levels to assess renal safety during treatment with empagliflozin by standard clinical laboratory assay (mg\u002FdL).","From baselinte to 12 months",{"measure":32,"description":33,"timeFrame":24},"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\u002Fg creatinine).",{"measure":35,"description":36,"timeFrame":24},"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\u002FL).",{"measure":38,"description":39,"timeFrame":24},"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\u002FL).",{"measure":41,"description":42,"timeFrame":43},"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 (%).","From baseline to 12 months.",{"measure":45,"description":46,"timeFrame":24},"Change in hematological parameters","Change in complete blood count parameters to evaluate hematological safety during treatment by standard clinical laboratory testing.",{"measure":48,"description":49,"timeFrame":24},"Change in blood pressure","Assessment of changes in both blood pressures (systolic and diastolic), by Standard sphygmomanometer measurement (mmHg).",{"measure":51,"description":52,"timeFrame":24},"Change in body weight","Change in body weight to assess tolerability and volume status during empagliflozin treatment by calibrated clinical scale (kg).",{"measure":54,"description":55,"timeFrame":24},"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.",null,{"allocation":56,"interventionModel":56,"interventionModelDescription":56,"primaryPurpose":56,"observationalModel":58,"timePerspective":59,"maskingInfo":56},"COHORT","PROSPECTIVE","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.\n\nThe project integrates translational and clinical components:\n\n1. validation of a urinary biomarker panel obtained through differential proteomics for early detection and monitoring of CKD progression, and\n2. evaluation of the effectiveness and safety of SGLT2i in routine clinical practice.\n\nA 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.\n\nThe 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.\n\nExploratory analyses will assess associations between urinary biomarkers and clinical outcomes.\n\nThe study follows Spanish regulations for observational studies with medicinal products (Real Decreto 957\u002F2020), with ethics approval and informed consent for biological samples.","Participants with chronic kidney disease (CKD) stages 2-4.",[63,68],{"label":64,"type":56,"description":65,"interventionNames":66},"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.",[67],"Drug: Empagliflozin",{"label":69,"type":56,"description":70,"interventionNames":56},"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).",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":56},"DRUG","Empagliflozin","Oral empagliflozin (10-25 mg daily) for 12 months",[64],[78,82],{"name":79,"affiliation":80,"role":81},"Carlos Martínez Salgado, PhD","University of Salamanca","PRINCIPAL_INVESTIGATOR",{"name":83,"affiliation":80,"role":81},"Pilar Fraile Gómez, MD, PhD",[85],{"name":79,"role":86,"phone":87,"phoneExt":56,"email":88},"CONTACT","+34616129633","carlosms@usal.es",[90],{"facility":91,"status":56,"city":92,"state":56,"zip":56,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Hospital Universitario de Salamanca","Salamanca","Spain","ES",{"type":96,"coordinates":97},"Point",[98,99],-3.67975,40.42972,{"lat":99,"lon":98},[102,103],{"name":79,"role":86,"phone":87,"phoneExt":56,"email":88},{"name":83,"role":86,"phone":104,"phoneExt":56,"email":105},"+34923291100","pilarfg@usal.es",{"type":107,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","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":117,"type":118},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.",[123],"Chronic Kidney Disease",[125,126,127],"SGLT2 inhibitors","empagliflozin","urinary biomarker","NOT_YET_RECRUITING","2026-01-12",{"date":131,"type":132},"2026-01-16","ACTUAL",{"date":134,"type":118},"2026-01",{"date":136,"type":118},"2028-03",{"name":5,"class":6},1]