[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603996":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":42,"responsibleParty":60,"collaborators":62,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SGLT2i","ACTIVE_COMPARATOR","Daily dose of SGLT2i (Forxiga 10 mg tablet)",[13],"Drug: SGLT-2 inhibitor",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Daily dose of placebo tablet",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","SGLT-2 inhibitor","The intervention in this clinical trial will be treatment with an SGLT2 inhibitor (Forxiga, 10 mg tablet once daily) compared with a matching placebo. A total of 88 non-diabetic kidney transplant recipients will be enrolled. All participants will be randomized in a 1:1 ratio to receive either Forxiga or placebo as an add-on to standard immunosuppressive therapy. This intervention differs from other studies by specifically targeting non-diabetic kidney transplant recipients, a population in which the efficacy and safety of SGLT2 inhibitors have not yet been established.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"The control intervention in this clinical trial will be a matching placebo tablet, identical in appearance to Forxiga (10 mg), administered once daily as an add-on to standard immunosuppressive therapy. A total of 88 non-diabetic kidney transplant recipients will be enrolled. All participants will be randomized in a 1:1 ratio to receive either placebo or Forxiga. This placebo intervention ensures blinding of both participants and investigators and allows a direct comparison of the safety and efficacy of SGLT2 inhibition versus no active treatment in this unique patient population.",[15],[31],{"name":32,"affiliation":33,"role":34},"Lotte B Lange, MD","Department of Nephrology, Odense University Hospital","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+45 40863392","lotte.borg.lange@rsyd.dk",{"name":32,"role":37,"phone":41,"phoneExt":26,"email":39},"+4540863392",[43],{"facility":44,"status":45,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Department of Nephrology, Odense University Hospital Kløvervænget 6, Enterance 93, 2. floor","RECRUITING","Odense","5000","Denmark","DK",{"type":51,"coordinates":52},"Point",[53,54],10.38831,55.39594,{"lat":54,"lon":53},[57,59],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":58},"Lotte.Borg.Lange@rsyd.dk",{"name":32,"role":37,"phone":26,"phoneExt":26,"email":39},{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[63,65,67],{"name":64,"class":6},"Aarhus University Hospital",{"name":66,"class":6},"Copenhagen University Hospital, Denmark",{"name":68,"class":6},"Gødstrup Hospital","100603996","phase-4-sglt2i-safety-and-efficacy-on-kidney-allograft-function-in-non-diabetic-kidney-transplant-recipients-100603996",false,"NCT07143773","SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients","SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Double-blind, Placebo Controlled, National, Multicenter Trial","SGL-TX-GFR","Inclusion Criteria:\n\n* Obtained written informed consent\n* Male or female patients, age ≥ 18 years.\n* Non-diabetic KTR\n* \\> 6 months post-transplant\n* eGFR\\> 25 ml\u002Fmin\u002F1.73m2 within the last 3 months pre randomization\n* Immunosuppressive must include Tacrolimus\n* Negative plasma hCG in fertile women\\*, and acceptance of the use of contraception during the course of the study.\n\nExclusion Criteria:\n\n* Patients treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization\n* eGFR\\\u003C 25 ml\u002Fmin\u002F1.73m2 (before randomization)\n* Alanine aminotransferase (ALAT) \\> 3 x upper normal limit\n* Bilirubin \\> 2 x upper normal limit\n* Pregnancy\n* Breastfeeding\n* Known allergy towards SGLT2i or the content substance\n* Known intestinal bowel disease","ALL","18 Years",{"count":80,"type":81},88,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","This clinical trial investigates whether 18 months of daily SGLT2i (10 mg Forxiga) preserves kidney function and evaluates safety, based on eGFR changes and adverse event occurrence in non-diabetic kidney transplant recipients.\n\nThe main questions it aims to answer are:\n\n* Does SGLT2i versus placebo, as an add-on to standard care, preserve kidney transplant function in non-diabetic recipients?\n* Is SGLT2i treatment safe for non-diabetic transplant recipients when evaluating adverse events?\n* Does SGLT2i versus placebo affect the occurrence of urinary tract infections, post-transplant diabetes mellitus (PTDM) and prediabetes incidence, U-ACR, as well as renal and cardiovascular parameters?\n\nResearchers will compare a daily dose of SGLT2i (10 mg Forxiga) with a placebo (a look-alike tablet with no active medicine).\n\nKidney transplant recipients who do not have diabetes can take part if they meet the study's requirements. Participants will be randomly assigned to receive either Forxiga or placebo once daily for 18 months. All participants will have check-ups every 3 months, which will include urine tests and blood samples. Neither the participants nor the study doctors will know which treatment they are receiving.",[87,88,89,90,91],"Kidney Transplantation Recipients","Sodium-Glucose Transporter 2 Inhibitors","Non-Diabetic Patients","Randomized Controlled Trial","Placebo Control Design",[9,93,94,95,96,97],"Kidney Transplant","Kidney Transplant Recipients","non-diabetic patients","Sodium-glucose Transporter 2 inhibitors","RCT","2025-08-22",{"date":100,"type":101},"2025-08-27","ACTUAL",{"date":103,"type":81},"2025-09-01",{"date":105,"type":81},"2027-08-01",{"name":5,"class":6},1]