[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-transplant-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-transplant-diabetes-mellitus":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100645401","phase-2-sglt2i-effect-on-ptdm-development-and-kidney-allograft-function-in-non-diabetic-kidney-transplant-recipients-a-randomized-doubleblind-placebo-controlled-national-multicenter-trial-100645401",false,"NCT07682350","SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial","SGL-TX-PTDM: SGLT2i Effect on PTDM Development and Kidney Allograft Function in Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial","SGL-TX-PTDM","Inclusion Criteria:\n\n* Obtained written informed consent\n* Male or female patients, age ≥ 18 years.\n* Non-diabetic KTR\n* Immunosuppressive must include Tacrolimus\n\nExclusion Criteria:\n\n* Patients who is 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* Positive plasma hCG\n* Breastfeeding\n* Known allergy towards SGLT2i or the content substance\n* Patients with chronic intestinal diseases, including inflammatory bowel diseases (e.g., Crohn's disease and ulcerative colitis) and structural conditions such as short bowel syndrome.","ALL","18 Years",{"count":20,"type":21},184,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can reduce the risk of developing post-transplant diabetes in kidney transplant recipients who do not have diabetes at the time of transplantation.\n\nThe main questions it aims to answer are:\n\n* Does Forxiga reduce the risk of developing post-transplant diabetes and prediabetes compared with placebo?\n* Does Forxiga help preserve the function of the transplanted kidney compared with placebo?\n* Is Forxiga safe for kidney transplant recipients who do not have diabetes?\n* Does Forxiga affect the occurrence of urinary tract infections, the amount of protein in the urine, and other kidney- and heart-related health measures compared with placebo?\n\nResearchers will compare Forxiga with a placebo (a look-alike tablet containing no active medicine) to see whether it can reduce the risk of post-transplant diabetes while maintaining kidney function and remaining safe to use.\n\nAdults who have recently received a kidney transplant and do not have diabetes may take part if they meet the study requirements.\n\nParticipants will be randomly assigned to receive either Forxiga or placebo once daily for 12 months. They will attend study visits 3, 6, and 12 months after joining the study. These visits will include health checks, blood tests, and urine tests. Neither the participants nor the study doctors will know which treatment each participant is receiving.",[27,28,29,30,31,32],"Kidney Transplant Recipient","Sodium Glucose Co-Transporter 2 Inhibitors","Non-Diabetic Patients","Randomized Controlled Trial (RCT)","Placebo Control Design","Post Transplant Diabetes Mellitus",[34,35,36,37,38,39,15],"SGLT2i","Kidney Transplant","Kidney Transplant Recipients","non-diabetic patients","Sodium-glucose Transporter 2 inhibitors","RCT","NOT_YET_RECRUITING","2026-06-26",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":21},"2026-09-01",{"date":48,"type":21},"2029-10-01",{"name":50,"class":51},"Odense University Hospital","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100549920","define-predictors-for-posttransplant-diabetes-mellitus-study-100549920","NCT06440330","Define Predictors for Posttransplant Diabetes Mellitus Study","DECODE","Inclusion Criteria:\n\n* Adult patients (≥18 years) with end stage kidney disease undergoing kidney transplantation with a deceased or living donor\n* Signed informed consent\n* Initial therapy with at least tacrolimus and corticosteroids\n\nExclusion Criteria:\n\n* Patients with a diagnosis of diabetes mellitus (either type 1 or type 2) prior to kidney transplantation\n* Treatment with GLP1-RA for weight losing purposes\n* Patients receiving a multi-organ transplantation\n* ABO incompatibility",true,{"count":61,"type":21},330,"OBSERVATIONAL","The primary aim of this prospective, multicentre study is to develop an accurate and convenient tool to predict the risk of PTDM at 3 months post-transplant, based on information on the day of transplantation (day 0).\n\nIn order to create such model, we will start by identifying individual predictor variables at the day of transplantation and subsequently explore the optimal combination of these predictors in multivariable models.\n\nSecondary objectives include:\n\n* Compare the performance of the model based on predictor variables at day 0 with existing models for prediction of PTDM (Chakkera, San Antonio Diabetes Prediction Model and Framingham Offspring Study Diabetes Mellitus algorithm)\n* Explore the glucose level evolution during the first 2 weeks after transplantation using continuous glucose monitoring, and its relationship with baseline patient characteristics and immunosuppressant drug use.\n* Evaluate the added value of incorporating information on glucose levels in the first and second weeks post-transplant to improve the PTDM prediction model.\n* Identify predictors for early post-transplant hyperglycemia (first 2 weeks post-transplantation)\n* Explore the correlation between early post-transplant hyperglycemia (fasting glycemia, pre-dinner glycemia) and PTDM at 3 months",[65,66],"Post-transplant Diabetes Mellitus","Kidney Transplant; Complications","RECRUITING","2024-05-27",{"date":70,"type":44},"2024-06-03",{"date":72,"type":44},"2023-09-01",{"date":74,"type":21},"2026-09-30",{"name":76,"class":51},"University Hospital, Antwerp",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":89,"studyType":62,"phases":4,"briefSummary":90,"conditions":91,"keywords":101,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100251946","european-transplant-registry-of-senior-renal-transplant-recipients-on-advagraf-100251946","NCT02558452","European Transplant Registry of Senior Renal Transplant Recipients on Advagraf","European Transplant Registry of Senior Renal Transplant Recipients Receiving Initial Immunosuppression With Tacrolimus Once Daily, Mycophenolate and Steroids","SENIOR","Inclusion Criteria:\n\n* Males or females, aged ≥65 years\n* Patients who received a renal allograft\n* Patients who are willing and able to participate in the study and from whom written informed consent has been obtained\n* Patients on an intended standard triple therapy with tacrolimus once daily (Advagraf with trough level ≥5ng\u002Fml) in combination with mycophenolate (either ≥1.0g\u002Fday MMF or ≥720mg\u002Fd EC-MPS) and Steroids (≥5mg prednisolone or equivalent)\n* Patient must have received primary or secondary renal allograft from a blood group compatible donor (either deceased or living)\n* Patients with low to standard immunological risk, who had a PRA 20% (PRA testing according to center's practice) or no known donor specific antibodies at transplantation\n\nExclusion Criteria:\n\n* Multi-organ recipients (solid organ or bone marrow)\n* More than secondary renal allograft recipients\n* Blood group A,B,O-incompatible allografts\n* Documented presence of donor specific antibodies (DSA)\n* Panel reactive antibody (PRA) \\>20% prior to transplantation (PRA testing according to center's practice)\n* Patients having received any other induction therapy than Basiliximab or depleting polyclonal antithymocyte antibodies (ATG) (e.g. OKT3, Campath)\n* Patients receiving Sirolimus, Everolimus, Azathioprine, Belatacept or Cyclophosphamide within 3 months prior to or at enrolment\n* History of alcohol or drug abuse with less than 6 months of sobriety\n* Patient with any condition that may affect absorption of immunosuppressives, (e.g. severe diarrhoea, gastrectomy, active peptic ulcer disease or clinically significant diabetic gastroenteropathy) or tacrolimus metabolism (e.g. liver cirrhosis)\n* Patient with mental dysfunction or inability to cooperate within the study\n* Patients who have been institutionalized by official or court order","65 Years",{"count":88,"type":21},1000,"10 Years","SENIOR transplant Registry European transplant registry of senior renal transplant recipients (above the age of 65 years) receiving initial immunosuppression with tacrolimus once daily, mycophenolate and steroids to investigate long term outcomes on an observational basis.",[92,93,94,95,96,32,97,98,99,100],"Graft Failure","Death","Acute Rejection of Renal Transplant","Infections","Bone Disease","Quality of Life","HLA Antibody Production","Cardiovascular Risk Factors","Non-HLA Antibody Production",[102,103,104],"elderly kidney transplant recipient","registry","tacrolimus once daily","2016-08-11",{"date":107,"type":21},"2016-08-12",{"date":109,"type":4},"2016-12",{"date":111,"type":21},"2028-01",{"name":113,"class":51},"Klemens Budde"]