[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-transplantation-recipients\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-transplantation-recipients":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,79,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100646533","phase-4-safety-and-efficacy-of-bite-in-desensitization-therapy-for-highly-sensitized-kidney-transplant-candidates-with-cpra--90-100646533",false,"NCT07689149","Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%","Inclusion Criteria:\n\n* Male or female participants aged 18 to 65 years.\n* Diagnosis of end-stage kidney disease and being evaluated for or awaiting kidney transplantation.\n* Calculated panel-reactive antibody level (cPRA) ≥90% and a kidney transplant waiting time of ≥5 years.\n* Previous treatment with a conventional desensitization regimen based on intravenous immunoglobulin and\u002For plasma exchange, with or without rituximab, with traceable medical records.\n* Persistent cPRA ≥90% or unacceptable HLA antibodies after conventional desensitization, resulting in failure to meet the immunological criteria for kidney transplantation.\n* Adequate nonrenal organ function to tolerate the study treatment, including left ventricular ejection fraction \\>50%, resting oxygen saturation \\>94%, AST and ALT \\\u003C3 times the upper limit of normal, total bilirubin \\\u003C34.2 μmol\u002FL, and no active infection.\n* Ability to understand the study procedures, provide written informed consent, and comply with study treatment and follow-up requirements.\n\nExclusion Criteria:\n\n* Inability to understand or comply with the study protocol or follow-up schedule.\n* Known or suspected hereditary complement deficiency.\n* Clinically significant central nervous system disease, including epilepsy, psychotic disorder, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, or cranial neuropathy requiring intervention.\n* AST, ALT, or GGT \\>3 times the upper limit of normal, or alkaline phosphatase or total bilirubin \\>1.5 times the upper limit of normal.\n* Acute myocardial infarction or unstable angina within 6 months before screening, severe cardiac arrhythmia, or New York Heart Association class III or IV heart failure.\n* Uncontrolled acute or chronic disease unrelated to end-stage kidney disease that may impair tolerance to study treatment.\n* Active or uncontrolled infection requiring systemic treatment.\n* Human immunodeficiency virus infection or uncontrolled active hepatitis B or hepatitis C infection.\n* Participation in another interventional clinical study within 3 months before screening or planned concurrent participation in another interventional study.\n* Previous treatment with another T-cell engager or bispecific T-cell-redirecting therapy.\n* Known severe hypersensitivity to blinatumomab, teclistamab, or any of their excipients.\n* Active malignancy.\n* Pregnancy, breastfeeding, or planned pregnancy during the study period.\n* Previous bone marrow transplantation, hematopoietic stem cell transplantation, or solid-organ transplantation other than kidney transplantation.\n* Receipt of a live vaccine within 30 days before screening or planned receipt of a live vaccine during study treatment.\n* Any other clinically significant condition that, in the investigator's judgment, may increase participant risk, interfere with study procedures, or affect safety or efficacy assessments.","ALL","18 Years","65 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","This study is a prospective, open-label, two-arm exploratory clinical trial aimed at evaluating the safety and efficacy of Bispecific T-cell Engager (BiTE) therapies in refractory, highly sensitized kidney transplant candidates. Patients with end-stage renal disease (ESRD) who have a calculated panel reactive antibody (cPRA) ≥ 90% and have waited for a transplant for over 5 years, despite receiving standard desensitization therapies (e.g., IVIG, plasmapheresis, rituximab), will be enrolled.\n\nA total of 20 participants will be randomized in a 1:1 ratio to receive either Blinatumomab (a CD19×CD3 BiTE) or Teclistamab (a BCMA×CD3 BiTE). The primary objective is to evaluate the desensitization response rate, defined as the reduction of cPRA to \\\u003C 20% or by ≥ 50% from baseline, assessed at multiple time points up to 1 year post-treatment. Secondary objectives include assessing the safety profile (such as the incidence of Cytokine Release Syndrome \\[CRS\\] and neurotoxicity), the extent of CD19+ B cell depletion, and the proportion of participants who successfully undergo kidney transplantation within 1 year.",[26,27],"Kidney Transplantation Recipients","HLA Sensitization",[29,30,31,32],"Bispecific T-cell Engager","Desensitization","Kidney Transplantation","HLA Antibodies","NOT_YET_RECRUITING","2026-07-04",{"date":36,"type":37},"2026-07-08","ACTUAL",{"date":39,"type":20},"2026-06-30",{"date":41,"type":20},"2029-12-31",{"name":43,"class":44},"West China Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100624883","parathyroidectomy-after-kidney-transplantation-100624883","NCT07415421","Parathyroidectomy After Kidney Transplantation","Subtotal Parathyroidectomy for the Treatment of Persistent Hyperparathyroidism After Kidney Transplantation","Para-KiT","Inclusion criteria\n\n* Age \\> 18 years and legally competent and able to understand spoken and written Danish\n* Kidney transplantation ≥6 months prior (no upper limit of time after transplantation)\n* Stable kidney graft function, defined as estimated GFR ≥ 30 ml\u002Fmin\u002F1.73m3\n* On minimum two separate biochemical measurements:\n\nPTH \\> upper normal limit of assay and\n\n* serum ionized calcium ≥1.33 mmol\u002FL or\n* serum total calcium ≥2.60 mmol\u002FL or\n* serum phosphate ≤0.60 mmol\u002FL despite sufficient dietary intake\n\nwith measurements obtained within\n\n* 3 months in patients 6-12 months post-transplant\n* 6 months in patients \\>12 months post-transplant\n\nand not attributable to calcium supplementation or treatment with thiazide diuretics or lithium.\n\nExclusion criteria\n\n* Inability to provide written, informed consent\n* Current anti-resorptive therapy (bisphosphonate, denosumab)\n* Current bone anabolic therapy (teriparatide, romosozumab)\n* Previous surgical parathyroidectomy\n* Not considered fit for surgery (including pregnancy)\n* Ionized calcium ≥1.50 mmol\u002FL or albumin-corrected calcium ≥3.00 mmol\u002FL despite discontinuation of calcium supplements.",{"count":54,"type":20},85,[56],"NA","This study aims to clarify whether surgical treatment of persistent hyperparathyroidism after kidney transplantation offers clinically meaningful benefits compared with a conservative treatment strategy.\n\nKidney transplant recipients (\\>6 mo after transplantation) with persistent hyperparathyroidism (elevated PTH and either hypercalcemia or hypophosphatemia) will be randomized in a 1:1 ratio to either subtotal parathyroidectomy or conservative management according to standard clinical practice. The study is conducted as an open-label, randomized controlled pilot trial with a 12-month follow-up period.\n\nOutcomes include bone density, physical function, quality of life and symptom burden.",[59,26],"Hyperparathyroidism",[61,62,63,64,65,66,67],"Persistent hyperparathyroidism","Kidney transplant recipients","Parathyroidectomy","Bone mineral density","Muscle function","Quality of life","Randomized controlled trial","RECRUITING","2026-06-25",{"date":71,"type":37},"2026-06-26",{"date":73,"type":37},"2026-03-03",{"date":75,"type":20},"2030-12-31",{"name":77,"class":44},"Aarhus University Hospital",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":78},"100622594","deceased-donor-kidney-storage-at-10-celsius-versus-conventional-storage-100622594","NCT07385651","Deceased Donor Kidney Storage at 10 Celsius Versus Conventional Storage","Participant inclusion criteria\n\n1\\. All adult single organ kidney transplant candidates on the waiting list at Vanderbilt University Medical Center (VUMC) will be eligible for enrollment.\n\nParticipant exclusion criteria\n\n1. Kidney transplant candidates less than 18 years old\n2. Kidney transplant candidates that decline consent\n3. Transplant candidates listed for multi-organ transplant\n\nDeceased donor organ inclusion criteria:\n\n1. Donation after brain death or donation after circulatory death kidney donors, whose health care proxy has consented for donation and the possibility of research\n2. Deceased donor kidneys that have been allocated to VUMC as a primary match offer prior to organ procurement will be eligible\n\nDeceased donor organ exclusion criteria:\n\n1. Donors whose health care proxy has declined consent for the possibility of research\n2. Deceased donor kidneys that have been allocated to VUMC as a backup offer\n3. Deceased donor kidneys that have been allocated to VUMC as a post procurement offer\n4. Deceased donor kidneys that have already been placed on ice",{"count":86,"type":20},30,[56],"The goal of this clinical trial is to test how storage temperature of deceased donor kidneys affects kidney function after transplant in adult patients receiving a kidney transplant.\n\nThe main question it aims to answer is:\n\n• Do patients that receive a kidney transplant stored at 10 °C have improved post-transplant kidney function? Researchers will compare patients who receive kidneys stored at 10 °C versus kidneys stored at 4°C (on ice, i.e. conventional storage) to see if kidneys stored at 10 °C have improved function.\n\nParticipants will:\n\n* Be made aware of and consent to receive a kidney transplant that had been stored at 10 °C\n* Have their urine collected 24 hours after surgery to be analyzed for research",[90,91,26],"End Stage Chronic Renal Failure","Chronic Kidney Disease (Stages 4 and 5)",[93,94,95,96],"kidney transplant recipients","delayed graft function","ischemia reperfusion injury","10 Celsius kidney storage","2026-04-03",{"date":99,"type":37},"2026-04-06",{"date":101,"type":37},"2024-11-18",{"date":103,"type":20},"2027-12",{"name":105,"class":44},"Vanderbilt University Medical Center",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":78},"100603996","phase-4-sglt2i-safety-and-efficacy-on-kidney-allograft-function-in-non-diabetic-kidney-transplant-recipients-100603996","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",{"count":115,"type":20},88,[23],"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.",[26,119,120,121,122],"Sodium-Glucose Transporter 2 Inhibitors","Non-Diabetic Patients","Randomized Controlled Trial","Placebo Control Design",[124,125,126,127,128,129],"SGLT2i","Kidney Transplant","Kidney Transplant Recipients","non-diabetic patients","Sodium-glucose Transporter 2 inhibitors","RCT","2025-08-22",{"date":132,"type":37},"2025-08-27",{"date":134,"type":20},"2025-09-01",{"date":136,"type":20},"2027-08-01",{"name":138,"class":44},"Odense University Hospital"]