[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549182":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":48,"collaborators":52,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Empagliflozin 10mg daily for 3 months (n=20)",[13],"Drug: Empagliflozin 10 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","NO_INTERVENTION","Participants will not take empagliflozin (n=20)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Empagliflozin 10 MG","Empagliflozin is a sodium glucose co-transporter 2 inhibitor (SGLT2i) that is approved for the treatment of chronic kidney disease (CKD) in persons aged 18 years or older",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Alexander J Kula, MD, MHS","CONTACT","312-227-6160","alexkula@luriechildrens.org",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Ann & Robert H. Lurie Children's Hospital of Chicago","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-87.65005,41.85003,{"lat":44,"lon":43},[47],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Alexander Kula","Assistant Professor of Pediatrics (Nephrology)",[53],{"name":54,"class":55},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100549182","early-phase-1-feasibility-trial-of-sodium-glucose-cotransporter-2-inhibitors-in-pediatric-chronic-kidney-disease-100549182",false,"NCT06430684","Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease","SGLT2I-IN-KIDS","Inclusion Criteria:\n\n* Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL\u002Fmin\u002F1.73m2\n\nExclusion Criteria:\n\n* Heart Disease\n* Diabetes\n* Pregnancy\n* Recipient of solid organ transplant\n* history of chemotherapy or stem cell transplant\n* moderate to severe persistent asthma\n* liver disease\n* class 2 or greater obesity\n* inability to follow study procedures due to cognitive impairment\n* obstructive uropathy or requirement for intermittent urinary catheterization\n* systolic blood pressure \\\u003C100mgHg\n* orthostatic hypotension\n* current use of an SGLT2i\n* anticipated need for titration of anti-hypertensives within 3 months\n* active use of any immunosuppressive medications\n* lack of clearance by primary nephrologist for participation","ALL","12 Years","25 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"EARLY_PHASE1","The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:\n\n1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?\n2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?\n\nParticipants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.\n\nStudy Procedures Include\n\n* For participants randomly selected for treatment, take empagliflozin once daily for 3 months\n* Phone calls with researchers every 2 weeks for check-ins\n* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests\n* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests",[74,75],"Chronic Kidney Diseases","Pediatric Kidney Disease",[77,78,79,80,81],"Sodium Glucose Co-Transporter 2 Inhibitor","SGLT2i","Pediatric CKD","Feasibility Study","Clinical Trial","2026-02-19",{"date":84,"type":85},"2026-02-20","ACTUAL",{"date":87,"type":85},"2024-08-23",{"date":89,"type":68},"2026-07-01",{"name":5,"class":6},1]