[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-tansplant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-tansplant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100603786","assessment-of-mineral-and-bone-disorders-in-kidney-transplant-recipients-100603786",false,"NCT07141043","Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients","New Directions and Perspectives in the Assessment of Mineral and Bone Disorders in Kidney Transplant Recipients","Inclusion Criteria:\n\n1. HD group: Patients undergoing HD for at least 12 months, aged 20-70 years, after signing an informed consent.\n2. KTR group: Patients with successful KTx performed at least 12 months prior to their enrollment, aged 20-70 years old, after signing an informed consent. Subjects will be eligible for inclusion regardless of KTx immunosuppression regimen, pre-transplantation history, history of pre-transplant dialysis, or whether the kidney donation was from a living or deceased donor.\n3. GPO group: men and postmenopausal women diagnosed with primary osteopenia or osteoporosis, aged 50-70 years old, after signing an informed consent.\n\nExclusion Criteria:\n\n1. HD group: Treatment with active bone therapies (excluding calcium and vitamin D); ongoing cancer treatment or recent history of malignancy, cirrhosis, recent major fractures, patients who have received transplants other than kidney, secondary causes of osteoporosis (other than CKD or transplant-related: primary hyperparathyroidism, hyperthyroidism, congenital bone disorders, sarcoidosis, severe bone trauma, malignant tumors, inflammatory bowel disease, endogenous Cushing syndrome, anti-estrogen\u002Fanti-androgen therapy, and anorexia nervosa), pregnancy and breast-feeding.\n2. KTR group: The same as for HD + return to dialysis + acute graft rejection.\n3. GPO group: The same as for HD + diabetes mellitus + prolonged glucocorticoid therapy (\\>7.5 mg Prednisone or equivalent for at least 3 months).",true,"ALL","20 Years","70 Years",{"count":21,"type":22},180,"ESTIMATED","OBSERVATIONAL","This study aims to integrate bone measurements (including bone turnover markers (BTM), bone mineral density (BMD) measurement, vertebral fracture assessment (VFA), trabecular bone score (TBS) ) commonly used in the general population for primary osteoporosis evaluation to enhance the assessment of CKD-MBD.",[26,27,28,29],"Hemodyalysis","Kidney Tansplant","Osteoporosis","CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder",[31,28,32],"CKD-MBD","bone turnover markers","RECRUITING","2025-08-18",{"date":36,"type":37},"2025-08-26","ACTUAL",{"date":39,"type":37},"2025-03-19",{"date":41,"type":22},"2027-06",{"name":43,"class":44},"Grigore T. Popa University of Medicine and Pharmacy","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100599179","daratumumab-for-late-antibody-mediated-rejection-100599179","NCT07081126","Daratumumab for Late Antibody-Mediated Rejection","Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients With De Novo Donor-Specific Antibodies: A Case-Control Study","DARTABMR","Inclusion Criteria:\n\n* Kidney transplant recipient (first or subsequent transplant)\n* Diagnosis of late ABMR (diagnosed \\>12 months post-transplant)\n* Biopsy-proven ABMR\n* Presence of de novo DSA\n\nExclusion Criteria:\n\n* Active infection\n* Other significant comorbidities that could affect outcomes or treatment safety\n* Contraindications to daratumumab\n* Prior treatment with daratumumab\n* Specific types of DSA (consider specifying, e.g., unacceptable antigens)\n* Non-adherence to standardized immunosuppression protocol (tacrolimus, MMF, steroids)\n* iFTA 2 or 3 on baseline biopsy","18 Years",{"count":56,"type":22},20,"INTERVENTIONAL",[59],"NA","The study titled \"Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients with De Novo Donor-Specific Antibodies\" (DARTABMR) is a case-control investigation assessing whether daratumumab is more effective than standard therapies (such as IVIG, plasmapheresis, and rituximab) in treating late antibody-mediated rejection (ABMR) in kidney transplant patients with new donor-specific antibodies (DSA). The research compares outcomes like kidney function stabilization, DSA reduction, and biopsy improvements between patients receiving daratumumab and those on standard treatments. Participants include transplant recipients diagnosed with ABMR more than 12 months post-transplant, with data collected on clinical, immunological, and biopsy parameters before, during, and after treatment. The study emphasizes matching participants based on key variables to minimize bias and will analyze treatment success rates, changes in kidney function and DSA levels, and adverse events.",[27,62],"Acute Rejection (AR) of Transplanted Kidney",[64,65,66],"daratumumab","kidney transplant","acute antibody mediated rejection","2025-07-15",{"date":69,"type":37},"2025-07-23",{"date":71,"type":37},"2025-07-01",{"date":73,"type":22},"2026-12-31",{"name":75,"class":44},"University Hospital, Martin"]