[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-transplant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-transplant":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,67,0,25,[9,51,78,104,132,160,185,215,253,276,304,330,361,394,423,447,473,504,528,560,585,607,631,655,684],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100652841","nrp--ex-situ-hmpo2-vs-nrp-alone-in-dcd-kidney-transplantation-100652841",false,"NCT07779187","NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation","Oxygenated Perfusion for Enhanced Renal Function in Donation After Circulatory Death (DCD) Kidney Transplants (OxyPERF) - A National Swedish Randomized Controlled Trial","OxyPerf","Inclusion Criteria:\n\nDonor kidneys:\n\n1. All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP.\n2. Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement)\n\nRecipients:\n\n1. All adult patients (\\>18 yrs old) eligible for renal transplantation during study duration.\n2. Recipient consented for surgery, matched to a DCD kidney.\n\nExclusion Criteria:\n\nDonor kidneys:\n\n1\\. Kidney allocated outside of Sweden according to Scandiatransplant allocation rules.\n\nRecipients:\n\n1. Paediatric patients (\\\u003C18 yrs old).\n2. Participation in other clinical drug or medical devices trials.\n3. Patient subject to combined transplant of kidney + other organ.","ALL","18 Years",{"count":21,"type":22},214,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:\n\n* Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone.\n* Are the postoperative complications and outcomes different between the two groups?\n* Is the quality of life of recipients different between the two groups?\n* Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes.\n\nParticipants will:\n\n* Receive a kidney treated with one of the two strategies.\n* Visit the clinic as per usual clinical practice for checkups and tests\n* Report on their quality of life pre and post transplant\n* Undergo a kidney biopsy at one year to forecast long term transplant function",[28,29],"Kidney Transplant","DCD Kidney",[31,32,33,34,35,36,37],"DCD kidneys","Normothermic Regional Perfusion (NRP)","Hypothermic oxygenated perfusion","Patient reported outcomes","Kidney transplants","Randomised Control Trial","Health economic analysis","NOT_YET_RECRUITING","2026-08-20",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":22},"2027-01-01",{"date":46,"type":22},"2030-12-31",{"name":48,"class":49},"Karolinska University Hospital","OTHER",3,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100593468","a-multicenter-prospective-blood-collection-study-in-a-kidney-transplant-population-100593468","NCT07006831","A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population","Accept cfDNA","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent\n2. Is 18 years of age or older at enrollment\n3. Had a kidney transplant prior to enrollment\n4. Is having an indication (for cause) biopsy as determined by clinician\n5. retrospective leftover samples are available from the kidney donor(s).\n\nExclusion Criteria:\n\n1. Is pregnant\n2. Had a blood transfusion within the past 4 weeks\n3. Had a transplant from an identical (monozygotic) twin\n4. Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).\n5. Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)\n6. Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)",{"count":59,"type":22},400,"OBSERVATIONAL","The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.",[63,28,64,65,66,67],"Kidney Disease","Transplant Recipient","Renal Function","Cell-free DNA","NGS","RECRUITING",{"date":41,"type":42},{"date":71,"type":42},"2025-11-14",{"date":73,"type":22},"2028-03",{"name":75,"class":76},"Devyser Inc.","INDUSTRY",6,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100652185","optimization-of-therapeutic-drug-monitoring-in-pediatric-kidney-transplant-100652185","NCT07769567","Optimization of Therapeutic Drug Monitoring in Pediatric Kidney Transplant","Optimization of Therapeutic Drug Monitoring for Tacrolimus and Mycophenolate in Pediatric Kidney Transplant Recipients: a PK\u002FPD Study","Inclusion Criteria:\n\n* Recipient of a solid organ transplant and at least 1 year of age\n* Receiving tacrolimus and\u002For mycophenolate\n* Patient and\u002For caregiver is willing to receive text notifications and has a mobile device capable of receiving and sending text and multimedia messages.\n* Ability to understand and willingness to sign a written informed consent\n* Ability to understand, read, and speak English.\n\nExclusion Criteria:\n\n* History of allergy to tape adhesives","1 Year",{"count":7,"type":22},"The goal of this observational, pharmacokinetic study is to evaluate factors that change drug exposure in pediatric kidney transplant recipients so investigators can make better dosing decisions. The main question it aims to answer is:\n\nCan investigators quantify the impact of factors that change with time (like food intake and medication adherence) on tacrolimus and mycophenolate? Our hypothesis is that inconsistent drug and food intake will increase day to day variability in drug exposure, and investigators can use this information to help us make decisions about what is the best dose.\n\nParticipants will participate in the study on 7 days over the course of 1 year. On day 1, participants will be asked questions to see if participants are able to be in this study. Investigators will ask what immunosuppression participants are taking, how tall and how much participants weigh.\n\nOn day 2, participants and their parent\u002Fguardian will be taught how to use the device to collect the blood samples and decide on which days to collect them.\n\nOn days 3-6, participants will collect blood samples 4 separate times over about 1 year. Collection days should try to be scheduled every 3 months (+\u002F- 2 weeks).\n\nOn each collection day, participants will collect a sample 7 different times over 9 hours. Each collection will only take approximately 5 minutes. Participants will be asked to collect a blood sample immediately before the morning dose of tacrolimus or mycophenolate, and 20 min, 1hr, 3hr, 4hr, 6hr, 9hr after the dose.\n\nAlso on collection days, participants will receive text messages and be asked to complete different assessments about their medications, diet, and how they feel by responding to the texts.\n\nOn day 7, participants will have the opportunity to participate in an interview where investigators will ask about participants' experience in the study.",[28],[90,91,92,93,94],"tacrolimus","mycophenolate","pharmacokinetics","pediatrics","microsampling","2026-08-17",{"date":97,"type":42},"2026-08-19",{"date":99,"type":22},"2026-09-01",{"date":101,"type":22},"2028-12-31",{"name":103,"class":49},"Children's Hospital Medical Center, Cincinnati",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100608632","phase-2-tnx-1500-in-kidney-transplant-recipients-100608632","NCT07204080","(TNX-1500) in Kidney Transplant Recipients","Phase II Clinical Trial Evaluating the Safety Efficacy of Fc-Modified Anti-CD154 mAB (TNX-1500) in Kidney Transplant Recipients","TONIX-1500","Inclusion Criteria:\n\n1. Male or female subjects ≥18 to 75 years of age.\n2. Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital.\n3. Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo)\n4. Ability to understand the study requirements and provide written informed consent.\n5. Epstein-Barr virus (EBV) seropositive\n\nExclusion Criteria:\n\n1. Recipient seropositive for human immunodeficiency virus (HIV-1), or hepatitis B surface antigen (HBsAg) or core antibody (Anti-HBc); subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment or spontaneous clearance.\n2. Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT.\n3. Subjects with a severe systemic infection, current or within the 2 weeks prior to screening.\n4. Left ventricular ejection fraction \\\u003C 40% as determined by TTE or clinical evidence of heart failure.\n5. Any of the following ocular history or ocular findings at screening exam:\n\n   1. Active inflammation in either or both eyes (does not include pigment cell in the AC after dilation); must be greater than trace cell or trace flare to exclude.\n   2. Findings that would impact the ability to monitor, diagnose, manage, and follow new onset ocular inflammation.\n   3. Receipt of ocular corticosteroids (topically, intravitreally, or periocularly) or has been treated with anti-VEGF intravitreal therapy within three months of Screening Exam\n6. Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.\n7. Women of childbearing potential (women capable of becoming pregnant) unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Highly effective contraception methods include:\n\n   1. Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment.\n   2. Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partners should be the sole partners for that subject.\n   3. Use of injected or implanted hormonal methods of contraception or other hormonal contraception that have comparable efficacy (\\\u003C1% for example, hormone vaginal ring or placement of a long-acting reversible contraceptives, an intrauterine device, or intrauterine system.\n   4. Total abstinence\n8. Use of other investigational products or enrollment in another investigational drug study within 30 days prior to screening or 5 half-lives, whichever is longer.\n9. Subjects with clinically significant lab abnormalities (\\>2.5 x the upper limit of normal (ULN) of the following liver function chemistries unless due to, as judged by the investigator, a benign underlying condition:\n\n   1. Alanine aminotransferase (ALT)\n   2. Aspartate aminotransferase (AST)\n   3. Alkaline phosphatase (ALP)\n   4. Bilirubin\n   5. Coagulation studies (international normalization ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT))\n10. Any other clinically significant medical condition, active infection, laboratory abnormality, or psychosocial condition (e.g. history of substance use disorder) that would, in the judgement of the investigator, impact the subject's ability to participate in the trial.\n11. Presence of pre-existing donor-specific antibodies (DSA) or calculated panel reactive antibodies (cPRA) \\>20% based upon results within 6 months prior to transplant.\n12. Virtual crossmatch (VXM) positive transplant with an MFI \\>1000 as assessed by routine methodology (Luminex)\n13. Cytomegalovirus (CMV) high risk combination: donor positive to recipient negative\n14. Multi-organ transplant or tissue recipient.\n15. History of malignancy of any organ system, except for localized excised non-melanomatous skin or carcinoma in situ of the cervix\n16. Subjects with any of the following: hemoglobin \\\u003C8 mg\u002FdL, white blood cell ≤2,000\u002Fmm3, or platelet count ≤75,000\u002Fmm3.","75 Years",{"count":114,"type":22},5,[116],"PHASE2","The primary objective is to investigate the safety of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.",[28,119,120,121],"Kidney Transplant Failure and Rejection","Immunosuppression","Immunosuppression After Kidney Transplantation",[28,123],"New Immunosuppression",{"date":97,"type":42},{"date":126,"type":22},"2026-11-01",{"date":128,"type":22},"2029-11-30",{"name":130,"class":49},"Ayman Al Jurdi, MD",2,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":18,"minAge":19,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":157,"locationsCount":159},"100651342","effects-of-propofol-and-sevoflurane-on-plasma-mirna-levels-n-living-kidney-donors-100651342","NCT07760402","Effects Of Propofol And Sevoflurane On Plasma Mirna Levels İn Living Kidney Donors","Comparative Effects of Propofol and Sevoflurane Anesthesia in Living Kidney Donors on Perioperative Plasma miR-146a, miR-155, and miR-21 Levels: A Randomized Prospective Comparative Trial","Inclusion Criteria:\n\n* Living kidney donors aged between 18 and 65 years.\n* Scheduled for an elective donor nephrectomy operation under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Body Mass Index (BMI) strictly less than 35 kg\u002Fm².\n* Provided written informed voluntary consent to participate in the study.\n\nExclusion Criteria:\n\n* Known history or clinical diagnosis of malignancy or Diabetes Mellitus (DM).\n* Active or history of chronic systemic inflammatory or autoimmune diseases.\n* Chronic use of analgesics or documented history of substance abuse.\n* Known hypersensitivity or allergic reaction to any of the anesthetic agents used in the study (Sevoflurane or Propofol).\n* Diagnosed with dementia, severe cognitive impairment, or any significant psychiatric disorder.",true,"65 Years",{"count":142,"type":22},34,[25],"Surgical interventions and associated tissue trauma induce a complex systemic inflammatory stress response characterized by the activation of neuroendocrine, metabolic, and immunological systems. Donor nephrectomy operations performed in living kidney donors are among the unique clinical models where these inflammatory cascades and cellular stress pathways are most intensely observed, due to major surgical trauma and unavoidable ischemia-reperfusion injury during organ clamping. Recent studies have demonstrated that microRNAs (miRNAs), which epigenetically regulate gene expression at the post-transcriptional level, serve as key determinants in perioperative medicine regarding immune response, resolution of inflammation, and cellular adaptation processes . Among our target molecules, miR-146a acts as a dominant, negative regulator (brake mechanism) of the innate immune response , while miR-155 plays an important role in the inflammatory response by triggering pro-inflammatory macrophage activation . Conversely, miR-21 displays an anti-apoptotic adaptation mechanism against tissue damage by directly targeting programmed cell death pathways . Propofol, an intravenous agent, and sevoflurane, a volatile anesthetic, are known to differentially impact microRNAs in circulating extracellular vesicles during major surgical interventions .\n\nThe original value of this study lies in being the first randomized clinical trial in the literature to comprehensively examine the acute comparative effects of these two anesthesia techniques on perioperative inflammatory miRNA expression profiles in completely healthy living kidney donors. The objective is to comparatively evaluate the dynamic changes in plasma miR-146a, miR-155, and miR-21 levels under general anesthesia maintained with propofol or sevoflurane.\n\nRegarding the methodology, the research will be conducted on 34 voluntary living kidney donors aged 18-65 in the ASA I-II risk group, scheduled for elective donor nephrectomy at Gaziantep University Faculty of Medicine Şahinbey Training and Research Hospital, Department of Anesthesiology and Reanimation. Donors will be allocated into two equal groups (Group P: Propofol, n=17 and Group S: Sevoflurane, n=17) using a computer-assisted block randomization method, with anesthesia maintenance titrated to a Bispectral Index (BIS) of 40-60. Peripheral venous blood samples will be collected into K3-EDTA tubes at three different time points: before anesthesia induction (T0: basal), at the end of surgery (T1), and at the postoperative 24th hour (T2). In accordance with project management and data privacy principles, personal identity information will be masked, and each participant will be recorded in the system with a unique \"File Number\" (Dosya No). In the molecular phase conducted in coordination with the Department of Medical Genetics laboratory, total RNA isolation and cDNA synthesis will be performed from plasma samples separated under cold chain rules. Expression levels of target genes and the U6 snRNA internal control will be quantitatively analyzed in duplicate using Real-Time Quantitative PCR (RT-qPCR). Fold change ratios will be calculated using the method and analyzed with biostatistical methods including Shapiro-Wilk, Student's t-test, and Mann-Whitney U test.\n\nAs for the widespread impact, the molecular findings to be obtained will elucidate the epigenetic reflections of general anesthesia applications on systemic inflammation and organ protection capacities for the first time. These results will lead to the development of the safest, evidence-based anesthesia protocols that will minimize the inflammatory load caused by surgical trauma at the cellular level in living kidney donors, increase donor comfort and postoperative recovery quality, and protect kidney graft quality against ischemic injury, providing a strong scientific foundation for international transplantation guidelines.",[28],[147,148,149,150],"Living donor","microRNAs","sevoflurane","propofol","2026-08-08",{"date":153,"type":42},"2026-08-12",{"date":155,"type":42},"2026-05-01",{"date":126,"type":22},{"name":158,"class":49},"University of Gaziantep",1,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":50},"100543101","detection-of-circulating-kidney-dna-in-kidney-transplant-patients-facing-an-episode-of-graft-rejection-100543101","NCT06351488","Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection","DART-RREGREF","Inclusion Criteria:\n\n* Age ≥ 18 ans\n* Patient living with at least one functioning kidney graft\n* Summoned to perform a kidney biopsy for cause\u002Findication at the Pitié Salpêtrière Hospital or at the Necker Hospital\n* Having been informed of the study and not opposing the study\n* Benefiting from a social security system (excluding AME)\n\nExclusion Criteria:\n\n* Under legal protection measure (curatorship or guardianship, under judicial protection).",{"count":168,"type":22},319,"In France, 3,500 kidney transplants are carried out per year; and 40,000 people succeed in 2019 with a kidney transplant. Despite regular medical monitoring, nearly 30% of transplant patients will develop rejection. Currently, only solid biopsy of the graft makes it possible to establish the diagnosis of graft rejection, and to characterize its cellular origin based on the Banff classification.\n\nSeveral studies have shown the possibility of identifying the tissue origin of DNA circulating in the blood, in healthy subjects, on the basis of the epigenetic properties of circulating DNA. In addition, in kidney transplant subjects, an increase in the quantity of circulating DNA originating from the graft in the blood and urine has been shown as well as an increase in urinary chemokine levels during renal dysfunction (notably dismiss). Thus, the company CGenetix in partnership with INSERM units 1155 and 1151 is developing a method to identify and characterize kidney transplant rejection early, through the detection of epigenetic biomarkers on circulating DNA targeting different fractions of the kidney (glomerular, tubular, peritubular capillary and vascular). The main objective is to study the diagnostic performance of the quantity of DNA of renal origin in kidney transplant patients in the blood and in the urine (expressed in copies\u002Fml) for the diagnosis of type Rejection mediated by kidneys. antibody (ABMR) established by kidney graft biopsy (gold standard) and according to the Banff 2022 classification.",[28,171],"Rejection",[173,174,175],"Graft rejection","renal circulating DNA","performance of the diagnostic test","2026-08-05",{"date":178,"type":42},"2026-08-10",{"date":180,"type":42},"2024-08-21",{"date":182,"type":22},"2027-06-21",{"name":184,"class":49},"Assistance Publique - Hôpitaux de Paris",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":193,"targetDuration":195,"studyType":60,"phases":4,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":159},"100635349","graftassure-lowering-allograft-rejection-by-combination--galactic-trial-100635349","NCT07551531","GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial","GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial: A Multi-Center Registry Study Assessing Transplanted Kidney Status","GALACTIC","Inclusion Criteria: Prospective Participant\n\n1. 18 years of age or older.\n2. ≥ 2 weeks post-kidney transplant at the time of first sample collection.\n3. Provides legally effective informed consent.\n4. Agrees to comply with all study procedures.\n\nInclusion Criteria: Historical Control Participant\n\n1. 18 years of age or older\n2. Has a minimum of three clinical evaluations per year post-transplant.\n\nExclusion Criteria: Prospective Participant\n\n1. Has received transplanted kidney from their identical twin.\n2. Has a history of another previously transplanted organ in situ, other than a prior kidney transplant.\n3. Has received an allogenic bone marrow graft or hematopoietic stem cell transplantation (HSCT).\n4. Self-reports as pregnant.\n5. Has a current malignancy, other than low-grade malignancy.\n6. Actively enrolled in another cfDNA assay-based trial.\n7. In the opinion of the investigator, participation in this study would pose a risk to data integrity or to the participant's safety and welfare.\n\nExclusion Criteria: Historical Control Participant\n\n1. Has received a kidney transplant from their identical twin.\n2. Has a history of another previously transplanted organ in situ, excluding previous kidney transplant.\n3. Has a current malignancy, other than low-grade malignancy.\n4. Self-reported pregnancy during the historical data time period.",{"count":194,"type":22},5000,"3 Years","The GALACTIC Registry study purpose is to validate the Combination Model-score (CM-score) for increased accuracy in the percentage of the positive predictive value (PPV) of allograft rejection results for the GraftAssure (GraftAssureCore and GraftAssureDx) assay. This will also be correlated with the biopsy yield and treatment decisions. The GraftAssure assay is a diagnostic test intended for the quantitative measurement of dd-cfDNA in plasma from kidney transplant recipients. The test is minimally invasive, and is intended to be used in conjunction with standard clinical assessment and other laboratory findings as an aid in the detection of allograft rejection.",[28],[199,200,201,202,203,204,205],"kidney transplant","dd-cfDNA","cell-free DNA","allograft rejection","donor derived cell-free DNA","kidney rejection","rejection","2026-07-29",{"date":208,"type":42},"2026-07-30",{"date":210,"type":22},"2026-06",{"date":212,"type":22},"2033-06",{"name":214,"class":76},"Insight Molecular Diagnostics",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":227,"conditions":228,"keywords":237,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":249,"leadSponsor":251,"locationsCount":50},"100624287","phase-3-prediction-and-prevention-of-bloodstream-infections-after-kidney-transplantation-100624287","NCT07407673","Prediction and Prevention of Bloodstream Infections After Kidney Transplantation","Prediction and Prevention of Bloodstream Infections After Kidney Transplantation - The PREDICT Study","PREDICT","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Kidney transplant recipient.\n3. Able to provide written informed consent.\n4. ≥1 urine sample with bacteriuria ≥10\\^5 CFU\u002FmL (excluding fungi) within first month post-transplantation.\n\nExclusion Criteria:\n\n1. Known strictures in the esophagus and\u002For obstructions in the gastrointestinal tract including diabetes gastroparesis.\n2. Known hypersensitivity or allergy to β-lactam antibiotics.\n3. Known or suspected genetic metabolism anomalies in the carnitine metabolism, including carnitine transporter defect or organic acidurias such as methylmalonic aciduria or propionic acidaemia.\n4. Individuals of Faroese descent (defined as both biological parents born in the Faroe Islands).\n5. Porphyria.\n6. Current treatment with valproic acid, valproate or other medications liberating pivalic acid.\n7. Current treatment with probenecid.\n8. Current treatment with methotrexate.\n9. Ongoing dialysis one month post-transplantation.\n10. Pregnancy or breastfeeding.",{"count":224,"type":22},180,[226],"PHASE3","Kidney transplant recipients take medicines that suppress the immune system to prevent rejection of the transplanted kidney. As a result, they have a high risk of infections, especially urinary tract infections (UTIs). Some of these infections can spread to the bloodstream and cause serious illness, hospitalization, loss of kidney function, or death. Currently, there is no established strategy to prevent these serious bacterial infections in kidney transplant recipients who are at highest risk.\n\nThe PREDICT study is investigating whether a low daily dose of the antibiotic pivmecillinam can reduce the risk of bacterial urinary tract infections and bloodstream infections after kidney transplantation. The study focuses on kidney transplant recipients who have bacteria detected in their urine during the first month after transplantation, as previous research suggests that these patients have a particularly high risk of developing serious infections later.\n\nIn this randomized, double-blind, placebo-controlled trial, 180 adult kidney transplant recipients will be assigned by chance to receive either pivmecillinam or a matching placebo from 1 to 6 months after transplantation. Neither participants nor study staff will know which treatment has been assigned during the study. All participants will continue to receive standard post-transplant care and monitoring.\n\nThe main goal of the study is to determine whether prophylactic pivmecillinam can reduce the occurrence of infections caused by Enterobacterales bacteria, including urinary tract infections and bloodstream infections, during the first 6 months after transplantation. The study will also evaluate the effects of treatment on serious clinical outcomes, safety, quality of life, antimicrobial resistance, and long-term kidney transplant outcomes.\n\nThe study hypothesis is that targeted antibiotic prophylaxis with pivmecillinam in kidney transplant recipients at increased risk of infection will reduce the incidence of Enterobacterales urinary tract infections and bloodstream infections during the high-risk period after transplantation compared with placebo.",[229,230,28,231,232,233,234,235,236],"Kidney Transplant Infection","Bloodstream Infection","Kidney Transplant Recipients","Infection","Urinary Tract Infection(UTI)","Urinary Tract Infection Bacterial","Antibiotic Prophylaxis","Bacteriuria",[238,239,240,241,242,243,244],"kidney transplantation","bloodstream infection","urinary tract infection","antibiotic prophylaxis","pivmecillinam","bacteriuria","Enterobacterales","2026-07-20",{"date":247,"type":42},"2026-07-22",{"date":44,"type":22},{"date":250,"type":22},"2041-07",{"name":252,"class":49},"Susanne Dam Nielsen, MD, DMSc",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":4},"100648382","immunosuppression-optimization-using-the-prospera-assay-in-kidney-transplant-recipients-impakt-100648382","NCT07718633","Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)","Immunosuppressant optiMization Using the Prospera Assay in Kidney Transplant (IMPAKT) Randomized Controlled Trial","IMPAKT","Inclusion Criteria:\n\n* Subjects received a kidney transplant in the prior 3 months.\n* Subjects receiving maintenance therapy consisting of tacrolimus, mycophenolate sodium or mycophenolate mofetil, and optionally corticosteroids, at the time of enrollment.\n* Subjects received induction therapy comprising IL2 receptor antagonist or thymoglobulin, or received no induction therapy.\n* 18 years of age or older at time of signing informed consent.\n* Able to read, understand and provide written informed consent, and willing and able to comply with the study requirements. If the subject is unable to sign the informed consent, a legally authorized representative (LAR) can consent on behalf of the subject.\n* Subjects are at the site standard-of-care MPA dosage\n\nExclusion Criteria:\n\n* Concurrent multiple solid organ or tissue transplants.\n* History of a previous organ transplant (aside from present kidney transplant), or cellular transplant.\n* DSA Positive according to local protocol, including either pre-transplant DSA positivity and de novo DSA positivity.\n* Any prior dd-cfDNA results ≥1.0% or ≥78cp\u002FmL after 28 days post-transplant.\n* ABO Incompatible donor.\n* A serious medical condition that may adversely affect ability to participate in the study (e.g, current diagnosis of cancer).\n* Pregnancy.\n* Received any induction therapy other than IL2 receptor antagonist or thymoglobulin.\n* Receiving any maintenance immunosuppression other than tacrolimus, mycophenolate sodium or mycophenolate mofetil, and prednisone.\n* Currently undergoing regular dialysis.\n* Considered high-risk at the time of enrollment, as per the treating physician.\n* Planned or ongoing use of other commercially available or investigational dd-cfDNA or blood-based gene expression profile assays for rejection surveillance, through randomization.",{"count":262,"type":22},750,[25],"IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.",[28,266],"Immunosuppresion",[28,120],"2026-07-17",{"date":247,"type":42},{"date":271,"type":22},"2026-07",{"date":273,"type":22},"2031-07",{"name":275,"class":76},"Natera, Inc.",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":287,"conditions":288,"keywords":292,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":159},"100647856","phase-2-cemiplimab-for-kidney-transplant-recipients-with-advanced-cutaneous-squamous-cell-carcinoma-100647856","NCT07715734","Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma","A Phase 2 Study of Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma (CONTRAC-2)","CONTRAC-2","Inclusion Criteria:\n\n* Histologically confirmed locoregionally advanced and unresectable or recurrent\u002Fmetastatic cutaneous squamous cell carcinoma (CSCC). Definitions that encompass unresectable disease include any of the following, after discussion at the multidisciplinary meeting:\n\n  * Anatomically unresectable disease to include carotid artery encasement; invasion into the skull base, cavernous sinus, sagittal sinus; pre-vertebral fascia\u002Fvertebral body\u002Fvertebral artery; disseminated distant metastatic disease\n  * Functionally unresectable disease resulting in the loss of sight, oral competency\u002Fspeech\u002Fswallowing, or limb\n  * Biologically unresectable disease to include satellitosis, in-transit\u002Fdermal metastasis, or disease which has failed 2 or more prior surgeries (by an experienced CSCC surgeon) or failed curative intent radiation therapy\n* Measurable disease per RECIST 1.1.\n* Received a kidney transplant. Must have a functioning allograft, be at least 6 months from last allograft transplantation, and have had no evidence of biopsy-proven allograft rejection (Banff 1A or above, requiring treatment) at any time. In order to be considered a functioning allograft, the following criteria must be met:\n\n  * Estimated glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin (using the CKD-EPI equation either by Cr or Cystatin C based measurement) (Inker LA et al, 2021)\n  * Baseline proteinuria \\\u003C 0.5 g\u002Fday (by spot urine protein-creatinine ratio or 24-hr urine collection, if available)\n  * Not receiving antiproliferative immunosuppressive medications. If patients are on antiproliferative immunosuppressive medications, they must be discontinued for at least 7 days before initiation of C1D1 (i.e. at the screening visit and\u002For during the lead-in period)\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Leukocytes ≥ 2.2 K\u002Fcumm\n  * Absolute neutrophil count ≥ 1.0 K\u002Fcumm\n  * Platelets ≥ 90 K\u002Fcumm\n  * Total bilirubin within normal institutional limits (except in cases where Gilbert syndrome is known or suspected, where total bilirubin should be \\\u003C 3 mg\u002FdL)\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x IULN\n* The effects of cemiplimab on the developing human fetus are unknown. For this reason, people of childbearing potential and people able to father a child must agree to use highly effective contraception prior to study entry, for the duration of study participation, and for 4 months after last dose of cemiplimab.\n* Able to switch immunosuppression regimen to sirolimus and prednisone if not already receiving sirolimus and prednisone as SOC.\n* Able to understand and willing to sign an IRB approved written informed consent document and willing and able to comply with clinic visits and study-related procedures. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Received chemotherapy or radiotherapy within 2 weeks prior to C1D1. Note: prior cetuximab exposure is permitted, but it must have been discontinued at least 2 weeks prior to the start of cemiplimab.\n* Received prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CLTA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (including chimeric antigen receptor \\[CAR\\] T-cell therapies).\n\nNote: prior topical or intralesional immunotherapies (e.g., imiquimod, talimogene laherparepvec) are permitted.\n\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial\n* Currently receiving any other investigational agents.\n* Unable to swallow pills.\n* Currently receiving any medications or substances that are strong inhibitors or inducers of CYP3A4.\n* Receipt of a live vaccine within 28 days of C1D1.\n* Receipt of COVID-19 vaccination within 7 days of C1D1 or for which the planned COVID-19 vaccinations would not be completed 7 days prior to C1D1.\n* Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression and if they are at least 4 weeks out from treatment. They must also be asymptomatic and on stable doses of anti-epileptic drugs (AEDs) and oral corticosteroids at the time of enrollment\n* A history of allergic reactions attributed to or known hypersensitivity to cemiplimab or any of its components or other agents used in the study.\n* Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments. Note: the following are not exclusionary: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded.\n* Any condition that requires ongoing\u002Fcontinuous corticosteroid therapy (\\> 10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 7 days prior to C1D1. Patients who require a brief course of steroids (up to 2 days in the week before C1D1) or physiologic replacement are not excluded.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active infection requiring hospitalization or treatment with IV anti-infectives within 14 days prior to C1D1; NYHA heart failure classifications of Class II, III, or IV; myocardial infarction or acute coronary syndrome within 12 months prior to C1D1; unstable angina pectoris; cardiac arrhythmia; transient ischemic attack or stroke within 12 months prior to C1D1.\n* Known non-infectious pneumonitis or any history of interstitial lung disease.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study entry.\n* Uncontrolled infection with HIV, hepatitis B or C infection, diagnosis of immunodeficiency, and\u002For tuberculosis (active or latent).\n\n  * Participants with known controlled HIV infection (undetectable viral load on HIV RNA PCR) and CD4 count \\> 350 either spontaneously or on a stable antiviral regiment are eligible. For these participants, monitoring will be performed as per local standards.\n  * Participants with HBsAg positive who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for hepatitis B) are eligible. Participants with controlled infections must undergo periodic monitoring of HBV DNA. Participants must remain on anti-viral therapy for at least 6 months beyond the last dose of cemiplimab.\n  * Participants with HBsAg negative but total HBcAb positive are permitted with the following requirements: if serum HBV DNA is above the limit of detection at screening, initiate HBV antiviral therapy before study entry. If serum HBV DNA PCR is below the limit of detection, periodic monitoring of HBsAg must be performed.\n  * Participants who are HCV Ab+ who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are eligible.",{"count":285,"type":22},22,[116],"This is a phase II, multicenter, open label, single arm, non-randomized trial using Simon's optimal two-stage design to evaluate the efficacy of cemiplimab in kidney transplant recipients with advanced cutaneous squamous cell carcinoma. The hypothesis being tested is that cemiplimab alongside standardized immune suppression will generate anti-tumor activity without triggering allograft rejection.",[289,290,291,28],"Kidney Transplant Recipient","Cutaneous Squamous Cell Carcinoma (CSCC)","Advanced Cutaneous Squamous Cell Carcinoma",[293,294,295],"Cutaneous squamous cell carcinoma","Advanced cancer","Kidney transplant","2026-07-11",{"date":245,"type":42},{"date":299,"type":22},"2026-09-30",{"date":301,"type":22},"2031-03-31",{"name":303,"class":49},"Washington University School of Medicine",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":159},"100647105","phase-4-letermovir-for-r-study-100647105","NCT07706166","Letermovir for R+ Study","An Interventional Study of Letermovir for Primary Prophylaxis of Cytomegalovirus Infection in Moderate Risk (R+) Abdominal Solid Organ Transplant Recipients","MISP CMV","Inclusion Criteria:\n\n* Adults who are at moderate risk for CMV after transplant (CMV IGG+, including D+\u002FR+ or D-\u002FR+)\n* Adults who received a kidney transplant, liver transplant, or any combination thereof\n\nExclusion Criteria:\n\n* Known contraindication to letermovir or its excipients\n* Current participation in another CMV related study\n* Unwilling or unable to participate in the study protocol",{"count":313,"type":22},146,[315],"PHASE4","The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV.\n\nParticipants will take letermovir for 84 days.",[28,318],"Liver Transplant",[320],"Moderate risk for CMV infection","2026-07-09",{"date":323,"type":42},"2026-07-15",{"date":325,"type":22},"2026-08",{"date":327,"type":22},"2029-08",{"name":329,"class":49},"University of Wisconsin, Madison",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":346,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":159},"100645741","remote-vs-in-person-prehabilitation-for-kidney-transplant-candidates-100645741","NCT07701382","Remote vs In-Person Prehabilitation for Kidney Transplant Candidates","Implementation of a Multimodal Prehabilitation Program for Patients With Advanced Chronic Kidney Disease Awaiting Deceased-Donor Kidney Transplantation: A Comparison of In-Person and Remote Delivery Models","KIDFIT","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Patients with advanced chronic kidney disease on the waiting list for deceased-donor kidney transplantation.\n* Ability to perform moderate-intensity physical exercise.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Absolute contraindication to physical exercise.\n* Severe cognitive impairment limiting participation in the intervention or assessments.\n* Active infection at the time of enrollment.\n* Clinically unstable medical condition.\n* Physical or musculoskeletal limitations preventing participation in the exercise program.",{"count":339,"type":22},84,[25],"Patients with advanced chronic kidney disease awaiting deceased-donor kidney transplantation frequently experience progressive functional decline, frailty, reduced mobility, and poor quality of life while on the transplant waiting list. Although multimodal prehabilitation programs based on exercise, nutritional optimization, and psychological support have shown promising benefits in major surgery, their implementation in kidney transplant candidates remains limited due to barriers related to accessibility, fatigue, transportation, and treatment burden.\n\nThis randomized single-center clinical trial aims to evaluate the feasibility, adherence, and effectiveness of a multimodal prehabilitation program in patients awaiting deceased-donor kidney transplantation, comparing an in-person supervised model with a remote home-based model supported by a digital platform. The primary outcome will be the change in functional capacity measured by the 6-Minute Walk Test (6MWT). Secondary outcomes include physical activity level, frailty, nutritional status, kidney disease-specific quality of life (KDQOL-36), postoperative recovery quality (QoR-15), postoperative complications, and program adherence.\n\nThe study seeks to generate clinically applicable evidence regarding the implementation and scalability of remote prehabilitation strategies in patients with advanced chronic kidney disease, with the potential to improve accessibility, sustainability, and perioperative outcomes in kidney transplantation.",[343,28,344,345],"Chronic Kidney Disease (CKD)","Frailty","Prehabilitation",[347,238,348,349,350,351,352],"advanced chronic kidney disease","prehabilitation","functional capacity","perioperative care","quality of life","multimodal prehabilitation","2026-07-08",{"date":355,"type":42},"2026-07-14",{"date":271,"type":22},{"date":358,"type":22},"2029-05",{"name":360,"class":49},"Hospital Clinic of Barcelona",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":377,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":159},"100645075","comparison-of-the-effects-of-general-anesthesia-and-combined-spinal-epidural-anesthesia-on-ferroptosis-humanin-and-mots-c-levels-in-renal-transplantation-100645075","NCT07678073","Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation","Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation: A Prospective Controlled Study","Inclusion Criteria:\n\n* Patients aged 18-70 years with American Society of Anesthesiologists (ASA) physical status I-III.\n* Patients scheduled for elective living-donor allogeneic kidney transplantation.\n* Patients receiving sevoflurane-based general anesthesia as the anesthetic technique.\n* Patients receiving combined spinal-epidural anesthesia as the anesthetic technique.\n\nExclusion Criteria:\n\n* Patients younger than 18 years or older than 70 years.\n* Patients undergoing deceased-donor kidney transplantation.\n* Patients receiving total intravenous anesthesia (TIVA).\n* Patients who decline to participate in the study or are unable to provide informed consent.\n* Patients with American Society of Anesthesiologists (ASA) physical status IV or V.\n* Patients with a history of previous organ transplantation.\n* Patients with known or suspected mitochondrial disorders.\n* Patients with a history of chronic corticosteroid use.\n* Patients requiring red blood cell transfusion intraoperatively or within the first 24 postoperative hours.\n* Patients with a primary warm ischemia time \\>5 minutes, secondary warm ischemia time \\>30 minutes, or cold ischemia time \\>60 minutes.","70 Years",{"count":370,"type":22},68,[25],"Renal transplantation is the most effective renal replacement therapy for patients with end-stage renal disease. Ischemia-reperfusion injury may adversely affect graft function and long-term outcomes. Ferroptosis has recently emerged as a potential mechanism involved in ischemia-reperfusion injury, while the mitochondrial-derived peptides humanin and MOTS-c are thought to exert protective effects against oxidative stress. However, the effects of different anesthetic techniques on these biomarkers in kidney transplant recipients have not been investigated.\n\nThis prospective controlled study aims to compare the effects of sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) on serum ferroptosis markers, humanin, and MOTS-c levels in adult kidney transplant recipients. Blood samples will be obtained perioperatively for biomarker analysis.\n\nThe primary objective of the study is to evaluate the effects of the anesthetic technique on serum ferroptosis markers, humanin, and MOTS-c levels. Secondary objectives include evaluating early graft function and postoperative outcomes by assessing the incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, length of hospital stay, and the association of these outcomes with perioperative biomarker levels.",[374,28,375,63,376],"Kidney Disease, End-Stage","Kidney","Renal Transplant",[378,379,380,381,382,383,384,385,386],"GENERAL ANESTHESIA","REGIONAL ANESTHESIA","KIDNEY TRANSPLANTATION","CELLULAR STRESS RESPONSE","CELLULAR STRESS","ANESTHESIA","HUMANIN","MOTS-c","FERROPTOSIS","2026-07-06",{"date":353,"type":42},{"date":390,"type":42},"2026-03-01",{"date":392,"type":22},"2026-10-15",{"name":158,"class":49},{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":409,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":159},"100565284","feasibility-and-plausible-effectiveness-of-a-lifestyle-intervention-in-kidney-transplant-recipients-heal-100565284","NCT06640179","Feasibility and Plausible Effectiveness of a Lifestyle Intervention in Kidney Transplant Recipients (HEAL)","Prevention of Weight Gain and Impaired Glucose Metabolism Post Kidney Transplantation: A Pilot and Feasibility Study","HEAL","Inclusion Criteria:\n\n* Receiving a kidney transplant within the prior 3-5 months, with the transplant received from a deceased donor or living donor. NOTE: The patient will be eligible for randomization at 3 months following the kidney transplant, or at a subsequent time once clearance from the kidney transplant physician is given, provided that the time does not exceed 5 months following the kidney transplant.\n* Both males and females of all race\u002Fethnic groups are eligible for participation in this study.\n* \\>=18 years of age.\n* Body mass index (BMI) \\>22 kg\u002Fm2. There is no maximal BMI provided that the weight does not exceed the weight allowance of the dual-energy x-ray absorptiometer (DXA) that is used to assess body composition (maximal weight for the DXA is 350 pounds).\n* Ability to provide informed consent prior to participation in this study.\n* Ability to provide clearance from their kidney transplant physician to engage in the diet and physical activity components of the proposed intervention and to safely complete the proposed outcome measures.\n* Ability to walk for exercise.\n\nExclusion Criteria:\n\n* Females who are pregnant, breastfeeding, or reporting a planned pregnancy during the study period. Female participants of childbearing age who are not currently taking contraceptive medication, are not post-menopausal, or have not been surgically sterilized will need to agree to use a double barrier method of contraception.\n* History of bariatric surgery.\n* Currently prescribed an anti-obesity medication.\n* Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic liver disease; cancer; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.\n* Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e., recent or recurrent DVT).\n* Resting systolic blood pressure of \\>=160 mmHg or resting diastolic blood pressure of \\>=100 mmHg or not on a stable medical treatment to control hypertension (stable dose is defined as the same dose and type of medication for a period of at least 6 months).\n* Eating disorders that would contraindicate modifying eating or physical activity behaviors.\n* Alcohol or substance abuse.\n* Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.) that is accompanied by the following: 1) not on a stable dose of medications for treatment within the previous 12 months, or 2) hospitalized for depression within the previous 5 years.\n* Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.",{"count":403,"type":22},60,[25],"The goal of this clinical trial is to learn whether if it is feasible to implement a study of patients receiving kidney transplantation, to learn if these patients will complete selective outcomes measurements, and to examine if a lifestyle intervention may assist with preventing weight gain compared to standard medical care. The main questions it aims to answer are:\n\n* Is it feasible to recruit and retain patients who have undergone kidney transplantation into a study to compare standard medical care to standard medical care plus a lifestyle intervention focused on prevention of weight gain?\n* Will participants engage in the interventions and be compliant to the components of the interventions?\n* Will there be any difference between the interventions between the interventions for the occurrence of adverse events specific to kidney transplantation?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on preventing weight gain compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on body composition compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting glucose compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on fasting insulin compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on insulin sensitivity compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical function compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on health-related quality of life compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on changes in dietary intake compared to standard medical care alone?\n* Will there be initial effectiveness for the standard medical care plus a lifestyle intervention to have a better effect on physical activity and sedentary behavior compared to standard medical care alone?\n\nParticipants will:\n\n* Participants will continue with their standard medical care following kidney transplantation.\n* Participants only receiving standard medical care will also complete brief monitoring visits at week 6, 12, and 18.\n* Participants receiving the lifestyle intervention will attend weekly intervention sessions and will be recommended to modify their diet and physical activity behaviors in an effort to prevent weight gain.\n* Participants will complete outcome measurements as the start of the study and again after 6 months in the study.\n* After 6 months in the study, participants will also complete a brief intervention and answer other questions about their experience in the study.",[28,407,408],"Overweight or Obese Adults","Glucose Control",[199,410,411,412,413],"overweight","obesity","glucose control","weight control","2026-06-30",{"date":416,"type":42},"2026-07-02",{"date":418,"type":42},"2024-12-17",{"date":420,"type":22},"2027-03-01",{"name":422,"class":49},"University of Kansas Medical Center",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":431,"targetDuration":433,"studyType":60,"phases":4,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":159},"100593807","alloreactive-memory-b-lymphocytes-and-anti-hla-sensitization-100593807","NCT07011238","Alloreactive Memory B Lymphocytes and Anti-HLA Sensitization","Alloreactive Memory B Lymphocytes and Anti-HLA Sensitization in Kidney Transplantation","ALLO-BMEM","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Rouen University Hospital patient monitored in the Nephrology and Kidney Transplantation Department, registered on the national kidney transplant waiting list\n* Carrier of HLA antibodies, including at least anti-HLA2, identified during the last screening\n* Notion of classic immune-promoting events including at least one previous transplant or pregnancy, or absence of a known immune-promoting event (naïve patient group)\n* Incompatible graft rate (IGR)\n\n  * IGR ≥ 85% (hyperimmunized patient group with anti-HLA polyreactivity) or\n  * IGR between 50% and 85% (immunized patient group with a more restricted repertoire of HLA reactivities) or\n  * IGR \\\u003C 50% (naïve patient group with no known history of immune-promoting events)\n* Person who has read and understood the information letter and does not object Not participating in the study\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Patients who have received rituximab in the previous year (B-cell depleting therapy)\n* Patients undergoing an HLA desensitization protocol using plasmapheresis and\u002For rituximab\n* Patients with an active infection\n* Persons deprived of their liberty by an administrative or judicial decision or persons placed under judicial protection\u002Fguardianship or curatorship",{"count":432,"type":22},51,"1 Day","In transplantation, B lymphocytes are major cellular players in the alloreactive humoral response through the production of antibodies targeting allogeneic HLA molecules expressed by the transplant. In subjects sensitized to HLA antigens, the contribution of pre-existing alloreactive memory B lymphocytes (Bmem) to allograft rejection phenomena after transplantation is now recognized. It has been proposed that the identification of these Bmem during the pre-transplant period could contribute to a better assessment of post-transplant immunological risk, allowing optimization of strategies to prevent humoral rejection. However, knowledge regarding the phenotypic and functional heterogeneity of Bmem as well as their clonal diversity is still extremely limited, not allowing discrimination between pathogenic and non-pathogenic alloreactive humoral responses. Such discrimination requires a better understanding of the modalities of differentiation of alloreactive B lymphocyte responses. To this end, this study aims to characterize the clonal, phenotypic and functional properties of alloreactive Bmem in subjects awaiting renal transplantation and sensitized to HLA antigens.",[28],[437],"B lymphocytes","2026-06-17",{"date":440,"type":42},"2026-06-22",{"date":442,"type":42},"2023-04-17",{"date":444,"type":22},"2028-06-17",{"name":446,"class":49},"University Hospital, Rouen",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":462,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":472},"100579938","phase-3-double-blind-randomized-placebo-controlled-multicenter-study-to-evaluate-the-efficacy-and-safety-of-ravulizumab-administered-intravenously-in-adult-participants-at-high-risk-of-delayed-graft-function-after-kidney-transplantation-100579938","NCT06830798","Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation","A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation","AWAKE","Inclusion Criteria:\n\n* ≥ 18 years of age at the time of signing the informed consent\n* Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD)\n* A candidate for kidney transplant from:\n\n  1. Donation after Circulatory Death (DCD) donor\n  2. High-risk Donation after Brain Death (DBD) donor\n\nExclusion Criteria:\n\n* Is to receive a kidney from a donor with category I,II,IV and V Maastricht Classification\n* Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.",{"count":456,"type":22},450,[226],"The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.",[460,461,28],"Delayed Graft Function","DGF",[460,461,28,463],"Ravulizumab",{"date":465,"type":42},"2026-06-18",{"date":467,"type":42},"2025-05-19",{"date":469,"type":22},"2028-08-30",{"name":471,"class":76},"Alexion Pharmaceuticals, Inc.",130,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":482,"conditions":483,"keywords":487,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":500,"leadSponsor":502,"locationsCount":159},"100641683","impact-of-culture-of-perfusion-fluid-on-donor-derived-infection-management-and-outcome-in-liver-and-kidney-transplant-100641683","NCT07651137","Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant","PREVENT","Inclusion Criteria:\n\n* Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods\n* Availability of graft preservation fluid culture results\n* Signed informed consent\n\nExclusion Criteria:\n\n* None",{"count":481,"type":22},1400,"This study aims to evaluate whether microbiological testing of the perfusion fluid used to transport transplanted organs can help predict the development of infections in liver and kidney transplant recipients, including possible donor-derived infections (infections transmitted from the donor organ).\n\nThe study will include all liver and kidney transplant recipients with available perfusion fluid culture results from 2021 until the start of the study (retrospective phase) and for two years after study initiation (prospective phase).\n\nThe study will assess how often high-risk microorganisms are identified in perfusion fluid, whether these findings are associated with complications or infections in recipients, and whether they affect patient outcomes, including mortality.",[484,229,318,28,485,486],"Liver Transplant Infection","Bacterial Infection","Donor-derived Infection",[488,489,490,491,492,493,494,199,495],"perfusion fluid","graft","transplantation","transplant recipients","infections","donor-derived infections","liver transplant","preservation fluid","2026-06-11",{"date":498,"type":42},"2026-06-16",{"date":99,"type":22},{"date":501,"type":22},"2029-08-31",{"name":503,"class":49},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":159},"100643751","phase-4-phenotype-guided-vasoactive-medication-during-kidney-transplantation-100643751","NCT07633600","Phenotype Guided Vasoactive Medication During Kidney Transplantation","Intraoperative Circulation Phenotyping to Guide Vasoactive Medication in Kidney Transplant Recipients","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Undergoing kidney transplantation at Cedars-Sinai Medical Center\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Patients unable to provide informed consent\n* Patients with contraindications to protocol vasoactive medications, as determined by the treating anesthesiologist\n* Patients in whom required intraoperative monitoring cannot be performed",{"count":512,"type":22},255,[315],"The goal of this clinical trial is to learn if vasopressin improves the body's response to intravenous fluids during kidney transplantation in patients who have relaxed blood vessels. Researchers will compare the results of vasopressin to those who received calcium chloride.",[28,516],"Fluid Management",[518,28],"Vasoactive Management","2026-06-04",{"date":521,"type":42},"2026-06-08",{"date":523,"type":22},"2026-06-01",{"date":525,"type":22},"2027-12-01",{"name":527,"class":49},"Jennifer Cutler",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":140,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":539,"conditions":540,"keywords":543,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":50},"100520402","phase-1-car-t-cell-therapy-for-desensitization-in-kidney-transplantation-100520402","NCT06056102","CAR-T Cell Therapy for Desensitization in Kidney Transplantation","Autologous Chimeric Antigen Receptor Engineered T Cell Immunotherapy for Desensitization in Patients Awaiting Kidney Transplantation","Inclusion Criteria:\n\n1. Male or female patients aged 18-65 years with kidney failure requiring hemodialysis.\n2. Patients must meet one of the following two criteria:\n\n   1. All the following:\n\n      * Protocol-specific cPRA ≥99.5%\n      * No suitable living donor OR has been active in a kidney paired donation program but not received a match within 12 months\n      * Have blood group Type O or B, and predictive of a positive virtual crossmatch to an available deceased donor.\n      * United Network for Organ Sharing (UNOS) listed for kidney transplant for at least 1 year\n   2. Protocol-specific cPRA ≥99.9% Protocol-specific cPRA must be rounded from three significant figures measured ≤90 days from the time of enrollment (i.e., cPRA of 0.994500 or 0.998500 would be eligible) using the web-based OPTN cPRA calculator (https:\u002F\u002Foptn.transplant.hrsa.gov\u002Fresources\u002Fallocation-calculators\u002Fcpra-calculator\u002F); accounting for HLA-A, -B, -C, -DRB1, -DRB3\u002F4\u002F5, and -DQB1 Luminex Single Antigen Beads (SAB) with MFI ≥3000; 1 archived sample within 6 months of screening required.\n3. Based on center-specific listing policies, a cPRA in UNet Waitlist that is ≥99.5% (the candidate must be eligible for additional priority of kidneys equivalent to individuals with a 100% cPRA)\n4. Able to understand and give written informed consent to participate in all aspects of the study.\n5. Willing to stay within 2 hours of the home study site for at least 28 days after the last T cell infusion\n6. Subjects of reproductive potential must agree to use contraception for at least one year after CAR T Cell infusion\n7. In the absence of contraindication, vaccinations must be up to date per the DAIT Guidance for Patients in Transplant Trials and include TdAP\n8. Positive for EBV capsid IgG\n9. Negative testing for latent TB infection within 3 months prior to enrollment. Testing should be conducted using either a PPD or interferon-gamma release assay (i.e. QuantiFERON-TB, T-SPOT.TB). Patients with a positive test for latent TB infection must complete appropriate therapy for Latent Tuberculosis Infection (LTBI). A subject is considered eligible only if they have a negative test for LTBI within 3 months prior to enrollment OR they have appropriately completed LTBI therapy prior to transplant. Latent TB infection treatment regimens should be among those endorsed by the CDC\n10. Hemoglobin ≥9g\u002FdL\n11. ANC ≥ 1,800\u002FμL, \\> 1,200\u002F μL for patients with Duffy-null associated neutrophil count (DANC)\n12. Absolute Lymphocyte Counts ≥500\u002FμL or CD3 T cell Count ≥150\u002FμL\n13. Platelet count ≥120,000\u002FμL\n\nExclusion Criteria:\n\n1. Subjects with indwelling catheters as primary access for hemodialysis\n2. Previous solid organ (except kidney) or bone marrow transplant\n3. BMI ≥35 kg\u002Fm\\^2\n4. Subjects who have preserved or oliguric urine output \\> 100 cc\u002Fday with history of recurrent UTI (2 in 6 months or 3 in 1 year, see study definitions)\n5. Subjects described in exclusion #4 with structural disease such as polycystic kidney disease, obstructive uropathy with nephrolithiasis or those otherwise at higher risk of urinary tract infections. Anuric subjects with structural kidney disease are not excluded\n6. Known active current or history of invasive fungal infection; any non-tuberculous mycobacterial infection that has been active or has required therapy within the last year. Any infection requiring hospitalization and IV antibiotics within 4 weeks of screening or PO antibiotics within 2 weeks\n7. History of HIV, chronic HBV, or chronic HCV, regardless of treatment\n8. Negative CMV serology\n9. Detectible viral load HBV, HCV, CMV, EBV, or BK by PCR\n10. Any B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment\n11. Receiving ongoing immunosuppression including corticosteroids \\>5mg\u002Fday, intravenous immunoglobulin, cyclophosphamide, tacrolimus, mycophenolic acid, or azathioprine from 30 days prior to study entry\n12. Active auto-immune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the investigator) autoimmune disease requiring prolonged immunosuppressive therapy, except Systemic Lupus Erythematosus that has been managed with a stable low dose of prednisone (5mg or less for at least 8 weeks) without other immunosuppressants or targeted biologics; or for renal-limited autoimmune conditions without risk for systemic manifestations (e.g. IgA nephropathy)\n13. Any chronic illness requiring uninterrupted anti-coagulation or anti-platelet therapy\n14. History of cirrhosis or severe liver disease, including abnormal liver profile (aspartate aminotransferase \\[AST\\], alanine aminotransferases \\[ALT\\] or total bilirubin \\> 3 times upper limit of normal at screening (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome)\n15. History of sickle cell disease, or systemic amyloidosis\n16. Cardiac clearance for transplant \\> 6 months old and\u002For any of the following: NYHA Class III or IV heart failure, unstable angina, left ventricular ejection fraction \\\u003C 40%, a history of recent (within 6 months) myocardial infarction or implantable cardioverter\u002F defibrillators and\u002For biventricular pacing.\n17. Moderate-severe pulmonary function abnormality, defined as resting oxygen saturation \\\u003C92% on room air or FEV1, TLC, or DLCO (after correction for hemoglobin) \\\u003C50% of predicted values\n18. Patients who have received any live vaccine within 30 days of planned leukapheresis\n19. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening\n20. Pregnant, currently breastfeeding, or planning to become pregnant during the primary or post-transplant follow up of the study.\n21. Past or current social or medical problems; or findings from physical examination or laboratory testing that are not listed above, which in the opinion of investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study\n\nLymphodepleting Chemotherapy Eligibility:\n\nStudy entry eligibility must be re-assessed prior to starting lymphodepletion. In addition, subjects must undergo respiratory viral testing on nasal or nasopharyngeal swabs (per institutional practice) for SARS-CoV-2 and influenza within 7 days prior to the first planned lymphodepletion chemotherapy.\n\n1. If the subject is positive for influenza, Tamiflu® or equivalent should be administered per package insert. The subject must complete treatment and symptoms must be improving and either resolved or nearly resolved in the judgment of the treating investigator prior to receiving lymphodepleting chemotherapy and CAR T cells. Repeat influenza testing is not required prior to initiating lymphodepleting chemotherapy and CAR T cell infusion.\n2. If the subject tests positive for SARS-CoV-2, the subject will be managed per institutional practice. Subject will be eligible to initiate lymphodepleting chemotherapy and CAR T cell infusion once cleared from requirement for isolation according to institutional and\u002For CDC guidance.\n3. If testing is positive for another respiratory virus (e.g., as part of a multiplex respiratory pathogen panel in the course of testing for influenza or SARS-CoV-2), the lymphodepleting chemotherapy and CAR T cell infusion will be delayed for at least 7 days to be sure clinical symptoms of a viral infection do not develop. If clinical symptoms develop, the lymphodepleting chemotherapy and CAR T cell infusion will be delayed until resolution of these symptoms.\n\nCAR T Cell Infusion Eligibility:\n\nThe criteria below will be assessed by the investigator following lymphodepleting chemotherapy and before administration of CAR T cells. Subjects who do not satisfy these criteria may have CAR T cell infusion delayed until such time as criteria are satisfied. Subjects who receive lymphodepleting chemotherapy but in whom CAR T cell infusion is delayed \\>4 weeks after the first day of lymphodepleting chemotherapy will receive a second cycle of lymphodepleting chemotherapy prior to CAR T cell infusion. For subjects receiving fludarabine, a second cycle of cyclophosphamide can be administered, but fludarabine will not be repeated.\n\n1. Subjects must not have developed deterioration in performance status or overall clinical condition or new laboratory abnormalities that would, in the opinion of the treating investigator, render it unsafe to proceed with CAR T cell infusion. The following are specific conditions that warrant delaying CAR T cell infusion:\n\n   1. Requirement for supplemental oxygen to maintain peripheral oxygen saturation ≥95%.\n   2. Presence of clinically significant radiographic abnormalities on chest x-ray. Chest x-ray is not required to evaluate for radiographic abnormalities in the absence of suggestive symptoms or exam findings.\n   3. New cardiac arrhythmia not controlled with medical management. EKG is not required to evaluate for arrhythmia in the absence of suggestive symptoms or exam findings.\n   4. Hypotension requiring vasopressor support.\n   5. Active infection: Diagnostic test results indicating new bacterial, fungal, or viral infection within prior 48 hours.\n2. Subjects must have adhered to restrictions on pre-infusion therapy.",{"count":536,"type":22},20,[538],"PHASE1","This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA.\n\nThe main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell.\n\nThe primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and\u002For recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.",[28,541,542],"Kidney Failure","End Stage Renal Failure on Dialysis",[295,544,545,546,547,548,549],"CART-BCMA","huCART-19","Highly sensitized","cPRA","UNOS waiting list","End stage renal failure patients with cPRA >99.5%","2026-05-19",{"date":552,"type":42},"2026-05-22",{"date":554,"type":42},"2024-05-09",{"date":556,"type":22},"2042-12-15",{"name":558,"class":559},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":566,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":18,"minAge":568,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":575,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":536},"100520364","phase-2-advancing-transplantation-outcomes-in-children-100520364","NCT06055608","Advancing Transplantation Outcomes in Children","Advancing Transplantation Outcomes in Children (CTOT-41)","ADVANTage","Inclusion Criteria:\n\n1. Participant and\u002For parent\u002Fguardian must be able to understand and provide informed consent\n2. Male or female, 13-20 years of age at time of enrollment\n3. Candidate for primary renal allograft from a living or deceased donor\n4. EBV IgG seropositive, defined as evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA)\n5. EBV VCA IgM seronegative OR EBV VCA IgM seropositive on two occasions at least 3 months apart and an undetectable EBV PCR result within 1 month prior to enrollment\n6. If a female participant of childbearing potential, a negative pregnancy test prior to conducting any study procedures\n7. If participant has reproductive potential, agrees to use Food and Drug Administration (FDA) approved methods of birth control for the duration of the study\n8. Negative test result for latent tuberculosis infection by tuberculosis skin test (purified protein derivative \\[PPD\\]) or Tuberculosis (TB) blood test (interferon gamma release assay \\[IGRA\\] i.e., QuantiFERON, T- SPOT.TB) within 12 months\n9. In the absence of contraindication, vaccinations must be up to date per the Centers for Disease Control and Prevention (CDC) Guidelines and Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials\n\nEnrollment criteria for donor source and age will be expanded using a stepwise approach determined by safety monitoring. Expansion criteria will include recipients down to age 6 and living donors. Safety data from each step will be reviewed by the study team, DSMB and FDA. If no safety concerns are identified, inclusion criteria will be expanded.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to comply with study protocol\n2. Active infection requiring treatment, or viremia\n3. History of malignancy\n4. Receipt of any licensed or investigational live attenuated vaccine(s) within 4 weeks of enrollment\n5. Prior history of organ transplantation\n6. Listed for multi-organ transplant (e.g. heart- kidney, liver-kidney, multivisceral- kidney, lung- kidney)\n7. Active systemic autoimmune disease at time of enrollment\n8. Idiopathic Focal Segmental Glomerulosclerosis (FSGS), Membranoproliferative Glomerulonephritis (MPGN), C3 glomerulopathy, or atypical Hemolytic Uremic Syndrome (HUS) suspected at risk for recurrence\n9. Use of immunosuppressants, biologics (including IVIG), chronic corticosteroids or investigational drug(s) within 8 weeks of enrollment\n10. Known bleeding disorder\n11. Sustained platelet count \\\u003C 75,000 cells\u002Fmicroliters within 3 months of enrollment\n12. History of inherited hypercoagulability requiring therapy more than aspirin\n13. Panel Reactive Antibody (cPRA) greater than 80 percent\n14. Clinically significant unrepaired congenital heart disease causing hemodynamic compromise\n15. Uncontrolled diagnosed psychiatric disorder or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements\n16. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study\n\nRandomization Inclusion Criteria:\n\nIndividuals who meet all of the following criteria are eligible for randomization.\n\n1\\. If EBV serology to meet enrollment criteria was performed within 8 weeks of receiving IVIG, EBV VCA IgG and EBV EBNA IgG seropositivity, confirmed between enrollment and time of transplant\n\nRandomization Exclusion Criteria:\n\nIndividuals who meet any of these criteria are not eligible for randomization.\n\n1. Sustained WBC \\\u003C1500 or \\>20,000 per microliter within 3 months of randomization\n2. Sustained liver function tests (AST and\u002For ALT) \\> 2x normal within 3 months of randomization\n3. Active systemic autoimmune disease at time of transplant\n4. Known bleeding disorder\n5. Sustained platelet count \\\u003C 75,000 cells\u002Fmicroliters within 3 months of enrollment\n6. Current (within 45 days) or historical anti-HLA antibody to the donor prior to randomization\n7. Recent recipient of any licensed or investigational live attenuated vaccine(s) within 4 weeks of randomization\n8. Panel Reactive Antibody (cPRA) greater than 80 percent at any point in time\n9. If a female participant of childbearing potential, a positive pregnancy test within 48 hours of randomization (all female participants of childbearing potential must complete a pregnancy test within 48 hours of randomization)\n10. Treatment with immunosuppressants within 8 weeks of randomization, except in the case of planned transplant standard of care\n11. Treatment with biologics (including IVIG) within 8 weeks of randomization","13 Years","20 Years",{"count":571,"type":22},200,[116],"This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.",[28],[199,576,577],"belatacept","sirolimus",{"date":579,"type":42},"2026-05-20",{"date":581,"type":42},"2024-05-22",{"date":583,"type":22},"2028-06-30",{"name":558,"class":559},{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":594,"conditions":595,"keywords":596,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":131},"100638744","perceptions-of-kidney-transplant-recipients-regarding-the-role-of-artificial-intelligence-in-medicine-100638744","NCT07600541","Perceptions of Kidney Transplant Recipients Regarding the Role of Artificial Intelligence in Medicine","AITX","* Inclusion criteria\n\n  * Age ≥ 18 years\n  * Fluency in French or English\n  * Electronic consent given\n* Exclusion criteria\n\n  * Severe cognitive impairment preventing comprehension\n  * Technical inability to access the questionnaire",{"count":593,"type":22},1000,"The AITX study is an international, multicenter survey exploring how kidney transplant recipients perceive artificial intelligence (AI) in medicine and, specifically, a system that predicts graft loss risk. Through an open-ended online questionnaire distributed across transplant centers and patient associations in France and the United States, the study captures patients' expectations, concerns, and the perceived impact of AI-driven prediction on their daily lives. Responses are analyzed using large language models (LLMs) with systematic human verification. The study aims to ensure that the deployment of AI in transplantation is ethical, transparent, and patient-centered.",[28],[597,598],"artificial intelligence","survey","2026-05-13",{"date":579,"type":42},{"date":602,"type":42},"2026-04-15",{"date":604,"type":22},"2026-12-30",{"name":606,"class":49},"Paris Translational Research Center for Organ Transplantation",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":23,"phases":616,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":159},"100638079","evaluation-of-an-instructional-video-about-medication-management-during-admission-and-medication-adherence-for-kidney-transplantation-and-in-the-outpatient-clinic-in-a-dutch-university-hospital-100638079","NCT07592624","Evaluation of an Instructional Video About Medication Management During Admission and Medication Adherence for Kidney Transplantation and in the Outpatient Clinic in a Dutch University Hospital.","MediT","Inclusion Criteria:\n\n* The patient is able to take the medication independently or with the help of someone else (professionals not included).\n* After admission, the patient is discharged to their own home or home of friend\u002Frelative.\n* The patient had a follow up at the outpatient clinic in the Erasmus Medical Center for at least one year after transplantation.\n* The patient is able to read the medication list or an illiteracy-friendly medication list.\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients who got discharged with a medication dispenser\n* Refusal to participate in the study.\n* Cognitive impairments that hinder participation.\n* Patients and\u002For family who can not understand (language barrier) the instructional video.",{"count":615,"type":22},308,[25],"The goal of this RCT is to evaluate the effect of the instructional video on improving patient compliance and reducing medication errors. The study will include adult kidney transplant recipients (18 years or older) at Erasmus MC who have undergone a kidney transplantation starting January 2026.\n\nThe main questions it aims to answer:\n\nThe primary aim of this study is to assess whether our developed video instruction, compared with the traditional verbal instruction, both of which are given shortly before training during admission, reduces the number of medication errors in kidney transplant patients.\n\nThe study will also examine the correlation between patient characteristics (such as age, comorbidities, and language proficiency) and medication errors. Additionally, patient-reported medication errors will be measured through a questionnaire completed during follow-up visits at the outpatient clinic, which is part of standard care.\n\nThe instructional video will be evaluated by a short questionnaire.",[28,619,620,621],"Adult","Medication Adherence","Instruction Videos","2026-05-11",{"date":624,"type":42},"2026-05-18",{"date":626,"type":22},"2026-07-01",{"date":628,"type":22},"2027-12-31",{"name":630,"class":49},"Erasmus Medical Center",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":23,"phases":640,"briefSummary":641,"conditions":642,"keywords":645,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":159},"100340034","phase-1-study-of-combined-kidney-and-blood-stem-cell-transplant-from-a-brother-or-sister-donor-100340034","NCT03707262","Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor","Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation and Rabbit Anti-Thymocyte Globulin","Recipient Inclusion Criteria:\n\n1. Males and females ages 18 years and older receiving living donor kidney transplant from an HLA-identical sibling at UCLA Medical Center.\n2. Agrees to participate in the study and is able to give informed consent.\n3. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three to six months of the trial at the physician's discretion.\n4. Meets institutional criteria for kidney and HSPC transplant.\n5. No known contraindication to administration of rATG or radiation.\n6. If patient is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status) patient must be confirmed not pregnant by a serum or urine pregnancy test) and must agree to practice a reliable form of contraception including hormonal treatments, barrier methods or intrauterine device for at least 12 months post-transplant. Karnofsky Performance Score ≥ 70.\n7. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.\n8. Adequate pulmonary function defined as FVC and DLCO of greater than or equal to 50% of predicted.\n9. Adequate liver function defined as total bilirubin ≤ 1.5 times the upper limit of normal and AST\u002FALT ≤ 2.0 times the upper limit of normal.\n10. Adequate social support based on evaluation by the UCLA renal transplant team licensed clinical social worker.\n\nRecipient Exclusion Criteria:\n\n1. Donor is identical twin.\n2. ABO incompatibility with donor.\n3. Previous solid organ transplant\n4. Multi-organ transplantation\n5. Previous treatment with rATG or a known allergy to rabbit proteins\n6. History of active malignancy within the past 5 years with the exception of non-melanomatous skin cancer.\n\n   a. History of another primary malignancy except for: i. Malignancy treated with curative intent and with no known active disease \\>2 years before the first dose of study treatment and of low potential risk for recurrence ii. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease iii. Very low risk and low risk cancer adequately treated or on active surveillance b. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, and DCIS)\n7. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n8. Leukopenia (with a white blood cell count \\\u003C 3,000\u002F µL) or thrombocytopenia (with a platelet count \\\u003C 100,000\u002F µL).\n9. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and\u002For C).\n10. Positive HLA DSA\n11. Seropositivity for HIV 1, HIV 2, HTLVI, HTLV II\n12. Active West Nile Virus infection\n13. Renal disease with high risk of recurrence (i.e., focal segmental glomerulosclerosis).\n14. Advanced hepatic fibrosis or cirrhosis secondary to hepatitis B and\u002For C diagnosis.\n15. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; active extra-renal autoimmune disease requiring immunosuppression.\n16. Active extra-renal autoimmune disease requiring immunosuppression.\n17. Neuropsychiatric illness that precludes the ability to give informed consent and\u002For places the patient as high risk for non-compliance with the safety monitoring requirements of the study.\n18. May not have received other immunosuppressive medications, including but not limited to alemtuzumab, belatacept, sirlolimus, everolimus, azathioprine, basiliximab, and eculizumab within six months of the study treatment. Use of corticosteroids prescribed for a time-limited indication (\\\u003C\u002F= 4 weeks) and stopped at least 4 weeks before the kidney transplant is acceptable.\n19. May not have received immunotherapy drugs such as immune checkpoint inhibitors (e.g. pembrolizumab, nivolumab, and ipilimumab), tumor necrosis factor inhibitors, rituximab, and interleukin-2 within six months of the study treatment.\n20. Current or active abuse of alcohol and\u002For drugs within last 6 months.\n21. BMI 40 or greater.\n\nDonor Inclusion Criteria:\n\n1. HLA-identical sibling on high-resolution HLA typing who is ≥18 years of age.\n2. Meets institutional criteria for living kidney and allogeneic HSPC transplant donation.\n3. Medically fit to tolerate peripheral blood apheresis, including weighing ≥110 pounds, hemoglobin ≥ 11 g\u002FdL, white blood cell count ≥ 3,000\u002FµL, and platelets ≥120,000\u002FµL.\n4. Normal serum chemistry and coagulation studies; or, if abnormal, the differences are not considered clinically significant.\n\nDonor Exclusion Criteria:\n\n1. Recipient is identical twin.\n2. ABO incompatibility with recipient.\n3. Medically unfit to tolerate peripheral blood apheresis (small body size, poor vascular access, not a suitable candidate for placement of a central catheter, etc.).\n4. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n5. Seropositivity for HIV 1, HIV 2, HTLV I, HTLV II\n6. Active West Nile Virus infection\n7. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and\u002For C)\n8. Psychiatric, addictive, neurological, or other disorder that compromises ability to give true informed consent for participation in this study\n\n   1. History of active malignancy within the past 5 years with the exception:Adequately managed malignancy within the past two years with low risk of recurrence may be acceptable as per clinician discretion\n   2. Adequately managed non-melanoma skin cancer\n   3. Adequately managed carcinoma in situ e.g., cervical cancer in situ, and DCIS\n9. No current or recent use of oral anti-coagulants. (For the purpose of this study, recent is defined as less than 60 days prior to apheresis.). Note: Use of aspirin and non-steroidal anti-inflammatory drugs, for pain and inflammation management purposes, are permitted to enroll in the study, but these drugs must be stopped 14 days prior to apheresis, however subjects who are taking aspirin for its anti-platelet\u002Fanti-thrombotic effect, are excluded.",{"count":639,"type":22},15,[538,116],"The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor.\n\nThe investigational treatment is started after kidney transplant. It begins with a regimen of a drug called rabbit anti-thymocyte globulin (rATG) combined with radiation therapy (known as total lymphoid irradiation, or TLI) to the lymph nodes and spleen. This is followed by an infusion of blood stem cells, which will be donated by the same sibling who donated their kidney. Researchers think that this treatment allows immune cells from the donor and recipient to live side by side, a condition referred to as \"mixed chimerism.\" Mixed chimerism may help create a state of \"tolerance\" in kidney transplant recipients in which all immunosuppressive medications can be stopped without rejection of the transplanted kidney.\n\nThis study will test whether (1) the investigational treatment will allow patients to stop immunosuppressive medications after their kidney transplant and (2) if the treatment impacts the rate of kidney rejection and the side effects of immunosuppressive medications.",[643,644,28],"Renal Transplant Rejection","Tolerance",[644,28],"2026-05-06",{"date":648,"type":42},"2026-05-08",{"date":650,"type":42},"2019-11-06",{"date":652,"type":22},"2027-05",{"name":654,"class":49},"Jeffrey Veale, MD",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":18,"minAge":663,"maxAge":4,"enrollmentInfo":664,"targetDuration":4,"studyType":23,"phases":666,"briefSummary":667,"conditions":668,"keywords":670,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":114},"100517155","phase-4-empagliflozin-treatment-in-kidney-transplant-recipients-100517155","NCT06013865","Empagliflozin Treatment in Kidney Transplant Recipients","An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR)","SEKTR","Inclusion Criteria:\n\n1. Adult (\\>18 years of age) male and female recipients (all races and ethnicities)\n2. Subject must be able to understand and provide consent\n3. Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant\n4. For subjects with T2DM or post-transplant diabetes (PTDM), measured kidney function by CKD epi eGFR must be 30mL\u002Fmin\u002F1.73m2 to 59 mL\u002Fmin\u002F1.73m2 or CKD epi eGFR 60 mL\u002Fmin\u002F1.73m2 with urinary albumin:creatinine ratio 30 mg\u002Fg (or protein:creatinine 100 mg\u002Fg).\n5. For subjects without T2DM or PTDM: measured kidney function by CKD epi eGFR must be 20mL\u002Fmin\u002F1.73m2 to 59mL\u002Fmin\u002F1.73m2 or CKD epi eGFR 60 mL\u002Fmin\u002F1.73m2 with urinary albumin:creatinine ratio 30 mg\u002Fg (or protein:creatinine 100 mg\u002Fg).\n\nExclusion Criteria:\n\n1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n2. History of prior pancreas transplant\n3. CKD epi eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 for those with T2DM or \\\u003C 20 mL\u002Fmin\u002F1.73m2 for those without T2DM or anyone with 5mL\u002Fmin\u002F1.73m2 fall in eGFR per year\n4. Uncontrolled type 2 diabetes mellitus with most recent A1C\\>12%\n5. History of \\>2 urinary tract infections per year or UTIs requiring admission in the last year, or urosepsis in the last year.\n6. Use of SGLT2i within 90 days\n7. Documented allergy to SGLT2i\n8. History of Type I diabetes mellitus\n9. History of diabetic ketoacidosis\n10. Indwelling foley catheter or urinary diversion\n11. Acute rejection in the prior 3 months\n12. Acute MACE event within 3 months of the study\n13. Severe congestive heart failure (NYHA functional class III or higher)\n14. Active mucocutaneous mycotic infection of the groin or external genitalia.\n15. History of amputation due to peripheral vascular disease and\u002For diabetic foot ulcers within prior year\n16. History of malignancy except non-melanoma skin cancer within 2 years of screening\n17. Known of active current viral, fungal, mycobacterial, or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease)\n18. HIV infected subjects, including those who are well controlled on anti-retrovirals\n19. Recent (within 6 months) Positive Hep B PCR or active disease\n20. Hepatitis C virus antibody positive (HCVAb+) subjects who have failed to demonstrate sustained viral remission for more than 12 weeks (after anti-viral treatment)\n21. Active pregnancy in a female transplant recipient\n22. A condition, in the eyes of the investigator, that precludes inclusion into the study.","19 Years",{"count":665,"type":22},264,[315],"Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.",[28,669],"Chronic Kidney Disease",[671,672,541,171,673],"Transplant","Diabetes","Proteinuria","2026-04-16",{"date":676,"type":42},"2026-04-21",{"date":678,"type":42},"2024-04-05",{"date":680,"type":22},"2030-03-31",{"name":682,"class":683},"VA Office of Research and Development","FED",{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":4,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":18,"minAge":691,"maxAge":692,"enrollmentInfo":693,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":695,"conditions":696,"keywords":697,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":699,"lastUpdatePostDateStruct":700,"startDateStruct":701,"completionDateStruct":702,"leadSponsor":704,"locationsCount":159},"100633876","personalized-stories-for-pediatric-kidney-recipients-100633876","NCT07532382","Personalized Stories for Pediatric Kidney Recipients","Generating Personalized Stories With Artificial Intelligence for Pediatric Kidney Recipients","Inclusion Criteria:\n\n* Age 5-12 years inclusive at enrolment.\n* Recipient of a kidney transplant.\n* Clinically stable at enrolment (no active rejection, acute infection, or current hospitalization for a graft-related complication).\n* Fluency in French or English.\n* Written informed consent from parent(s)\u002Flegal guardian(s); child assent when age-appropriate.\n\nExclusion Criteria:\n\n* Severe cognitive impairment precluding engagement with narrative content.\n* Mental state not allowing participation.\n* Family unwilling or unable to commit to the study timeline and interview requirements.","5 Years","12 Years",{"count":694,"type":22},100,"Pediatric kidney transplant recipients often face major psychosocial challenges that are difficult to address with existing tools. This study evaluates whether clinically supervised AI can generate personalized, age-adapted therapeutic stories for these children and their families.",[28],[698],"Artificial intelligence","2026-04-08",{"date":602,"type":42},{"date":390,"type":42},{"date":703,"type":22},"2026-12-01",{"name":606,"class":49}]