[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-transplantation":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,45,0,25,[9,48,79,112,146,185,216,243,274,304,343,373,398,431,453,497,519,544,569,599,625,650,672,700,729],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100573312","phase-2-phase-2-study-of-alxn2030-in-patients-with-antibody-mediated-rejection-after-kidney-transplantation-100573312",false,"NCT06744647","Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation","A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients With Antibody-Mediated Rejection After Kidney Transplantation","CONCORD","Inclusion Criteria:\n\n* Kidney transplant received ≥ 6 months\n* Active or chronic active AMR according to Banff 2022 classification, based on Screening kidney biopsy\n* Either positive C4d on Screening kidney biopsy based on the Central Pathology Laboratory report and\u002For positive HLA Class I and\u002For II antigen-specific DSA as determined by the local laboratory's definition of positivity using single-antigen bead based assays\n* MVI score ≥ 2 (g ≥ 1 and ptc ≥ 1)\n* eGFR ≥ 30 mL\u002Fmin\u002F1.73 m2\n* Must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) at least 14 days prior to but no more than 3 years prior to Day 1\n* Must be vaccinated for S pneumoniae prior to randomization\n* Must be vaccinated for H influenzae type B (where available) prior to randomization\n* Body weight ≥ 50 kg at Screening\n\nExclusion Criteria:\n\n* Biopsy-based diagnosis of any of the following at Screening:\n* TCMR, according to the Banff grade ≥ 1\n* Polyoma virus nephropathy\n* Severe thrombotic microangiopathy\n* Glomerulonephritis\n* ABO-incompatible transplant\n* uACR \\> 2200 mg\u002Fg\n* Multiorgan transplant recipient (except for previous multiple kidney transplants) or cell transplant (islet, bone marrow, stem cell) recipient\n* Planned or recent treatments, \\\u003C 90 days prior to the Screening Visit and during Screening, for Acute Rejection, AMR (including plasmapheresis, plasma exchange, IVIg, B-cell depleting therapy, IL inhibitors, proteasome inhibitors, high-dose corticosteroids \\[except for tapering\\]), HDS products with known hepatotoxic ingredients, TCMR (including T-cell depleting therapy), excluding the SoC immunosuppressant treatment which will be allowed and should be stable during the entire treatment.\n* Known medical or psychological condition, including substance abuse or use disorder (including alcohol), or risk factor that may interfere with study participation, pose additional risk, or confound study outcomes","ALL","18 Years","75 Years",{"count":5,"type":22},"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.",[28,29,30,31],"Antibody-Mediated Rejection","Kidney Transplantation","Biopsy-proven Histologic Scores","AMR",[33,28,29,34,31],"ALXN2030","Biopsy-proven histologic scores","RECRUITING","2026-06-17",{"date":38,"type":39},"2026-06-18","ACTUAL",{"date":41,"type":39},"2025-03-07",{"date":43,"type":22},"2028-11-07",{"name":45,"class":46},"Alexion Pharmaceuticals, Inc.","INDUSTRY",55,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100579450","phase-2-evaluation-of-dipyridamole-in-preventing-post-transplant-hypophosphatemia-in-kidney-transplant-recipients-100579450","NCT06824454","Evaluation of Dipyridamole in Preventing Post-Transplant Hypophosphatemia in Kidney Transplant Recipients","Inclusion Criteria:\n\n* Adult kidney transplant patients.\n* No known contraindications to Dipyridamole\n\nExclusion Criteria:\n\n* Contraindications to Dipyridamole.\n* Patients with delayed graft function (defined as the need for dialysis within seven days post-transplantation).\n* Patients requiring Plavix, direct oral anticoagulants (DOACs), or Coumadin.",{"count":55,"type":22},90,[25],"The primary goal is to determine if Dipyridamole can improve serum phosphate levels and reduce the need for phosphate supplementation.",[59,29],"Hypophosphatemia",[61,62,63,64,65,66,67],"Post-kidney transplant care","Dipyridamole","Renal phosphate loss","Serum phosphate levels","Phosphate supplementation","Transplant graft function","Kidney transplant complications","2026-06-09",{"date":70,"type":39},"2026-06-11",{"date":72,"type":39},"2025-05-15",{"date":74,"type":22},"2027-05",{"name":76,"class":77},"Stanford University","OTHER",1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":4},"100643135","the-adaptive-platform-trial-for-kidney-disease-100643135","NCT07595952","The Adaptive Platform Trial for Kidney Disease","APT-KIDNEY: The Adaptive Platform Trial for Kidney Disease","APT-KIDNEY","Eligibility Criteria - Inclusion\n\n1. Adults with age ≥18 years\n2. eGFR \\\u003C30 ml\u002Fmin\u002F1.73m² for ≥3 months or end-stage kidney disease on dialysis or Kidney transplant with functioning graft (any eGFR)\n3. Ability to provide informed consent\n4. Meets eligibility criteria for at least one currently active APT-KIDNEY domain\n\nEligibility Criteria - Exclusion\n\n1. Refusal to provide informed consent\n2. Participation in another interventional trial whose protocol prohibits co-enrollment in APT-KIDNEY\n3. Any condition that, in the investigator's judgment, makes participation in any APT-KIDNEY domain unsafe or impractical",{"count":88,"type":22},5000,[90],"NA","Background: Randomized clinical trials (RCTs) are essential for evaluating intervention effects but are often challenged by regulatory and logistical burdens, high costs, and extended timelines. To address these challenges, the 'Adaptive Platform Trial in Kidney Disease' (APT-KIDNEY) will establish an investigator-initiated platform trial built on a unified regulatory, contractual, and operational framework. The platform emphasizes adaptive, cost-efficient methodology, automated data capture via linkage to electronic health records and administrative registers, and stakeholder engagement.\n\nObjectives: The primary objective of APT-KIDNEY is to establish an adaptive platform trial for evaluation of multiple interventions in patients with advanced kidney disease as defined by an estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m2 or end-stage kidney disease (ESKD) on dialysis or conservative care.\n\nStudy design: APT-KIDNEY is a pragmatic, randomized, embedded, multifactorial, adaptive platform trial with interventions organized into domains, emphasizing low-intervention comparisons. Domains may be open-label or blinded and will be able to use response-adaptive randomization, adaptive stopping and arm-dropping, and adaptive enrichment to enhance efficiency and relevance where applicable.\n\nStudy population: Adults (≥18 years) with advanced kidney disease defined by eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 for ≥3 months or ESKD on hemo- or peritoneal dialysis who are eligible for ≥1 one domain. Key exclusions include inability to provide informed consent; domain-specific exclusions may apply, but eligibility cannot be broadened beyond the core protocol.\n\nTrial outcomes: Core outcomes will be all-cause mortality, major adverse cardiovascular events (nonfatal myocardial infarction, nonfatal ischemic stroke, or cardiovascular death), and health-related quality of life (EQ-5D-5L).\n\nAbbreviated methods: APT-KIDNEY will permit domains to use frequentist and\u002For Bayesian methods. Primary analyses will target prespecified primary estimands and be conducted using the full analysis set. Prespecified sensitivity analyses will assess robustness to alternative strategies for intercurrent events and missing data, including per-protocol and as-treated supportive analyses. Outcomes are analyzed with generalized linear\u002Fmixed models and time-to-event methods with covariate adjustment. Frequentist analyses will be fixed-sample or group-sequential; results will be reported with 95% CIs and p-values, and Bayesian analyses will report posterior effects with 95% credible intervals and posterior probabilities. Bayesian domains will primarily use neutral, mildly skeptical priors. Multiplicity will be controlled at the domain level by a prespecified hierarchy: primary comparisons will precede secondary outcomes. Advanced adaptive domains will be evaluated by simulation to quantify operating characteristics including, power and Type I error, and the impact of outcome delays and missing data.\n\nPerspectives: APT-KIDNEY will establish an enduring, investigator-led platform for pragmatic, embedded nephrology trials, reducing start-up time and administrative burden through a shared regulatory and operational framework. Using standardized core outcomes and automated follow-up via electronic health records and national registers, it will generate faster, comparable, practice-relevant evidence across multiple interventions.",[93,94,95,96,29],"Kidney Disease","Chronic Kidney Disease (Stages 4 and 5)","End-Stage Kidney Disease (ESKD)","Dialysis",[98,99,100,101],"Chronic kidney disease","Kidney transplantation","End-stage kidney disease","Platform trial","NOT_YET_RECRUITING","2026-06-08",{"date":105,"type":39},"2026-06-10",{"date":107,"type":22},"2026-10-01",{"date":109,"type":22},"2066-12-31",{"name":111,"class":77},"Nicholas Carlson",{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":119,"targetDuration":121,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":129,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100643721","evolution-of-physical-frailty-and-patient-reported-outcome-measures-in-kidney-transplant-candidates-a-mixed-methods-longitudinal-study-protocol-100643721","NCT07607041","Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol","Longitudinal Tracking of Physical Frailty and Health-Related Quality of Life Through Patient-Reported Outcome Measures in Adult Candidates on the Kidney Transplant Waiting List","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Diagnosed with Stage 5 chronic kidney disease (CKD).\n* Currently undergoing clinical evaluation for or actively listed on the deceased-donor kidney transplant waiting list at Hospital del Mar (Barcelona).\n* Cognitive and physical ability to understand and provide written informed consent.\n* Ability to use or have regular access to a digital device (smartphone or tablet) for electronic Patient-Reported Outcome Measures (ePROMs) completion.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or active psychiatric disorders that prevent the reliable completion of questionnaires or physical tests.\n* Major physical disability that precludes the objective assessment of gait speed or handgrip strength (e.g., bilateral lower limb amputation or severe dominant hand deformity).\n* Acute medical illness requiring hospitalization at the time of enrolment.\n* Total language barrier that prevents understanding the study components or the qualitative interview.",{"count":120,"type":22},150,"24 Months","OBSERVATIONAL","This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time. During this period, some patients become \"frail.\" This means they lose strength and are at a higher risk for health problems.\n\nThe main goal is to follow these patients over time to better understand their needs. Researchers will use a mobile application to collect Patient-Reported Outcome Measures (PROMs) directly from patients about how they feel and their quality of life. The study will also include personal interviews to learn about the patients' experiences and any difficulties they face when using technology.\n\nThe results of this study will help to: • Identify early which patients are losing strength or health. • Improve the support that nurses provide during the transplant waiting period. • Make sure that digital health tools are easy for everyone to use.\n\nIn short, this work aims to help patients reach the day of their surgery in the best possible condition.",[125,126,127,29,128],"Kidney Failure, Chronic","Frailty","Quality of Life","Patient Reported Outcome Measures",[29,130,131,132,133,134,135,136,137],"Waiting Lists","Health-Related Quality of Life","Digital Health","Longitudinal Studies","Mixed Methods Research","Hermeneutics","Patient-Centered Care","Technology Assessment, Biomedical","2026-06-05",{"date":103,"type":39},{"date":141,"type":22},"2026-07",{"date":143,"type":22},"2028-07",{"name":145,"class":77},"Hospital del Mar",{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":159,"conditions":160,"keywords":165,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":78},"100640982","phase-1-immunological-reset-to-enable-access-to-hla-compatible-kidney-transplantation-in-highly-sensitized-patients-reset-100640982","NCT07607197","Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)","Immune Reset to Allow Access to Hla-compatible Kidney Transplantation in Hyperimmunized Patients","HIPER-RESET","Inclusion Criteria:\n\n* Patients aged between 18 and 60 years.\n* Diagnosis of end-stage kidney disease (ESRD) currently maintained on chronic dialysis.\n* Highly sensitized\u002Fhyperimmunized status, defined by a high calculated Panel Reactive Antibody (cPRA) level (e.g., \\>= 95%).\n* Active status on the deceased-donor kidney transplant waiting list.\n* Adequate bone marrow, hepatic, cardiac, and pulmonary function to safely undergo the conditioning regimen and AHSCT.\n* Capable of understanding the study requirements and providing written informed consent.\n\nExclusion Criteria:\n\n* Contraindications to the conditioning regimen medications (rituximab, cyclophosphamide, or rATG).\n* Active, uncontrolled systemic infection, or chronic active infection (including HIV, active Hepatitis B or C, or active tuberculosis).\n* Significant cardiac dysfunction (e.g., Left Ventricular Ejection Fraction \\\u003C 50%) or severe underlying pulmonary disease.\n* History of malignant neoplasm within the past 5 years, excluding successfully treated non-melanoma skin cancer or carcinoma in situ.\n* Previous autologous or allogeneic hematopoietic stem cell transplantation.\n* Pregnancy or breastfeeding.\n* Any psychiatric, medical, or geographical condition that, in the investigator's opinion, prevents compliance with the protocol and long-term follow-up.","60 Years",{"count":156,"type":22},10,[158,25],"PHASE1","The purpose of this clinical trial is to evaluate whether a temporary reprogramming of the immune system can help highly sensitized (hyperimmunized) patients with end-stage kidney disease safely receive a compatible kidney transplant.\n\nPatients who are highly sensitized have developed an extremely high level of antibodies against human leukocyte antigens (HLA), often due to previous transplants, pregnancies, or blood transfusions. This condition makes it nearly impossible for them to find a compatible organ donor, leaving them stuck on dialysis indefinitely.\n\nThis study tests an innovative strategy using Autologous Hematopoietic Stem Cell Transplantation (AHSCT). The procedure involves an intensive conditioning regimen using a combination of medications (cyclophosphamide, thymoglobulin, and rituximab) to deeply clear out the patient's existing mature immune cells. This is followed by the reinfusion of the patient's own previously collected and purified blood stem cells (CD34+ cells) to rebuild the immune system from scratch.\n\nThe investigators hypothesize that this procedure will eliminate the \"immunological memory\" cells responsible for producing the problematic anti-HLA antibodies, resetting the immune system to a \"naive\" or inactive state. This immune reset is expected to eliminate or significantly lower circulating HLA antibodies, creating a critical window of opportunity for these patients to successfully receive a compatible kidney transplant from the deceased-donor waiting list.",[125,29,161,162,163,164],"Alloimmunization","HLA Sensitization","End Stage Cronic Kidney Disease","Highly Sensitized Patients Awaiting Kidney Transplant",[166,167,29,168,169,170,171,172,173,174,175],"Autologous Hematopoietic Stem Cell Transplantation","AHSCT","Highly sensitized","Hyperimmunized","Desensitization","Anti-HLA Antibodies","CD34+ Cells","Transplant Immunology","End-Stage Kidney Disease","Immune Reset","2026-06-02",{"date":178,"type":39},"2026-06-04",{"date":180,"type":39},"2024-02-01",{"date":182,"type":22},"2028-06",{"name":184,"class":77},"Hospital Universitari Vall d'Hebron Research Institute",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":4},"100638170","phase-4-low--vs-standard-dose-tmp-smx-for-prevention-of-pneumocystis-pneumonia-after-kidney-transplantation-100638170","NCT07619027","Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation","A Prospective Randomized Controlled Study of Low-Dose Versus Standard-Dose Trimethoprim-Sulfamethoxazole for the Prevention of Pneumocystis Jirovecii Pneumonia After Kidney Transplantation","TMP-SMX PJP","Inclusion Criteria:\n\n-Age: Between 18 and 70 years old. Transplant Status: Recipients of a first-time kidney transplant. Renal Function: Serum creatinine levels have stabilized with a creatinine -----clearance (CrCl) \\> 30 mL\u002Fmin.\n\nConsent \\& Compliance: Voluntarily agree to participate in this study, are capable of cooperating with the investigators, and have signed the informed consent form.\n\nExclusion Criteria:\n\n-HIV Infection: Known HIV positive status. Drug Allergy: History of allergy or hypersensitivity to TMP-SMX (Trimethoprim-Sulfamethoxazole).\n\nPrior PJP: History of Pneumocystis jirovecii pneumonia (PJP) before transplantation.\n\nG6PD Deficiency: Glucose-6-phosphate dehydrogenase deficiency. Multi-organ Transplant: Recipients of multi-organ transplants. Active Infection: Presence of other severe concurrent infections. Immune System Disorders: Concomitant diseases affecting the immune system (e.g., malignancies\u002Ftumors, connective tissue diseases, hematological system diseases).\n\nPregnancy: Pregnant women. Anemia: Megaloblastic anemia. Non-compliance: Inability to adhere to regular follow-up schedules or poor compliance.","70 Years",{"count":195,"type":22},1084,[197],"PHASE4","This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of low-dose versus standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) for the prevention of Pneumocystis jirovecii pneumonia (PJP) in kidney transplant recipients.\n\nParticipants will be randomly assigned to receive either low-dose or standard-dose TMP-SMX for 12 months after kidney transplantation. The primary outcome is the incidence of PJP during the prophylaxis period. Secondary outcomes include adverse events related to TMP-SMX, dose reduction or discontinuation rates, incidence and timing of PJP after discontinuation, and other post-transplant complications.\n\nParticipants will be followed for a total of 24 months, including a 12-month prophylaxis period and an additional 12-month follow-up period after discontinuation. This study aims to provide evidence for optimizing prophylactic strategies against PJP in kidney transplant recipients.",[200,29],"Pneumocystis Jirovecii Pneumonia",[202,203,204,205],"PJP prophylaxis","Kidney transplant recipients","Trimethoprim-Sulfamethoxazole","Low-dose","2026-05-26",{"date":208,"type":39},"2026-06-01",{"date":210,"type":22},"2026-06",{"date":212,"type":22},"2030-06",{"name":214,"class":215},"Anhui Provincial Hospital","OTHER_GOV",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":224,"maxAge":193,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":239,"leadSponsor":241,"locationsCount":78},"100610221","phase-1-study-to-evaluate-the-safety-and-efficacy-of-the-ggta1-ko-thymokidney-in-patients-with-esrd-100610221","NCT07224763","Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD","EXTEND: A Prospective Study to Evaluate the Safety and Efficacy of GGTA1 KO Thymokidney XenoTransplantation in Patients With End-stage Renal Disease (ESRD)","EXTEND","Inclusion Criteria for all Participants (Groups 1 and 2):\n\n1. Provide voluntarily informed consent to participate in the study and for lifetime follow-up.\n2. Have a diagnosis of ESRD at the time of informed consent.\n3. Hemodialysis dependent for a minimum of 6 months and has a functioning arterial-venous fistula\u002Fgraft or permanent catheter at the time of informed consent.\n4. 50 to 70 years of age at the time of informed consent, or 40 to \\\u003C50 years of age with a calculated panel reactive antibody (cPRA) of ≥99.9%.\n5. Evidence of thymic involution on chest computed tomography (CT) scan with a thymic region of interest score of ≤1.\n6. Live within 3 hours travel time of the xenotransplant center.\n7. Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth control, if the possibility of conception exists.\n8. Negative xeno-crossmatch at Screening and pre-transplant.\n9. Estimated Post Transplant Survival Calculator score \\>20%.(https:\u002F\u002Foptn.transplant.hrsa.gov\u002Fdata\u002Fallocation-calculators\u002Fepts-calculator\u002F).\n10. Body mass index ≤35 kg\u002Fm2.\n11. Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention-recommended courses of age- and risk-factor-appropriate vaccinations.\n12. Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.\n\nAdditional Inclusion Criteria for Group 1:\n\n1\\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:\n\n1. Ineligible for a living donor transplant.\n2. Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).\n3. Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).\n\nAdditional Inclusion Criteria for Group 2:\n\n1. On an OPTN kidney transplant waitlist (active or inactive status).\n2. No approved living kidney donors.\n3. More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for \"Choose your state\" field and National average for \"Choose your transplant program\" field; https:\u002F\u002Fwww.srtr.org\u002Ftools\u002Fkidney-transplant-decision-aid\u002F).\n\nExclusion Criteria (pertain to all participants in Groups 1 and 2):\n\n1. Need for multiple organ transplants.\n2. Severe medical co-morbidities including, but not limited to:\n\n   1. Chronic liver disease.\n   2. Advanced cardiovascular disease.\n   3. Severe peripheral vascular disease that limits technical ability to transplant the GGTA1 KO Thymokidney.\n   4. Severe neurologic diseases or conditions that would preclude meaningful recovery or informed consent.\n   5. Oral steroid-dependent airway disorder or chronic pulmonary disease or requires chronic, intermittent, or continuous supplemental oxygen.\n   6. Pulmonary hypertension.\n   7. Uncontrolled diabetes or sequelae of diabetes mellitus including severe non-proliferative diabetic retinopathy.\n   8. Severe neurogenic bladder that requires intermittent catheterization.\n3. ESRD due to hereditary or structural kidney disease.\n4. Active or recently treated malignancy at the time of informed consent.\n5. Non-renal cause of hematological disorders associated with anemia (eg, thalassemia and sickle disease).\n6. Cannot discontinue chronic anticoagulation therapy (low-dose daily aspirin is permissible).\n7. History of major psychiatric disorders with psychiatric hospitalization and\u002For suicidal ideation within 5 years of informed consent.\n8. Being treated for active tuberculosis (TB), have received prophylaxis for positive FDA-approved interferon-gamma release assay, or test positive for TB by FDA-approved interferon-gamma release assay test during Screening.\n9. Nucleic acid test (NAT) positive for hepatitis B virus and\u002For hepatitis C virus, hepatitis B surface antibody (anti-HBs) titer \\\u003C10 mIU\u002FmL unless the participant is determined to be a nonresponder to hepatitis B vaccination (a nonresponder is defined as having an anti-HB titer \\\u003C10 mIU\u002FmL after having completed both the standard vaccine series and a fourth booster dose and\u002For second standard vaccine series), and\u002For positive for human immunodeficiency virus (HIV; HIV-1 and HIV-2 antibody and\u002For NAT).\n10. Not able to independently perform activities of daily life.\n11. Have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation (eg, history of substance use disorder \\[SUD\\] within 1 year of informed consent, lack of social support, untreated psychological conditions).","40 Years",{"count":226,"type":22},50,[158,25],"The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2).\n\nThe study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.",[230,29,231],"ESRD (End-Stage Renal Disease)","Xenotransplantation",[233,234,231,235],"End-stage renal disease","ESRD","GGTA1 KO Thymokidney",{"date":237,"type":39},"2026-05-27",{"date":210,"type":22},{"date":240,"type":22},"2076-03",{"name":242,"class":46},"United Therapeutics",{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":259,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":273},"100579855","ttv-based-management-of-long-term-immunosuppression-in-kidney-transplantation-100579855","NCT06829719","TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation","Personalization of Maintenance Immunosuppression Based on TTV Viral Load to Prevent Long-term Complications in Renal Transplantation","TAOIST","Inclusion Criteria:\n\n* Adult ≥ 18 years-old\n* Recipient of a kidney allograft (third graft at most)\n* 12 to 48 months post-transplantation\n* Stable graft function (defined as: delta creatininemia over the previous 6 months \\\u003C 20% and proteinuria \\\u003C 30mg\u002Fmmol)\n* On maintenance immunosuppression, which includes CNI (cyclosporin or tacrolimus) and MMF (Cellcept or Myfortic) with or without corticosteroids\n* Detectable TTV DNAemia at enrollment\n* No circulating DSA in solid phase assay\n* Undetectable BKV DNAemia at enrollment\n* Written informed consent\n\nExclusion Criteria:\n\n* Recipient of an HLA identical graft\n* Mutiple organ transplantation or functional transplant other than kidney\n* Maintenance immunosuppression that includes a mTOR inhibitor, belatacept or imurel\n* Presence of histological sign of active rejection (i+t \\> 2 and g+cpt \\> 2) on graft biopsy performed within 3 months before enrollment\n* Uncontrolled infection at inclusion\n* Infection requiring hospitalization within 3 months before inclusion\n* Diagnosis of a cancer of interest between the (current) transplantation and inclusion\n* Pregnant, unwillingness to practice adequate contraception or patient with a pregnancy plan during 3 years of study\n* Person not affiliated to a social security scheme or beneficiary of a similar scheme\n* Person subject to a legal protection measure (guardianship, curatorship) or deprived of liberty",{"count":252,"type":22},600,[90],"Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. The development of non-invasive biomarkers to guide the management of therapeutic immunosuppression beyond the first year post-transplantation is therefore a crucial unmet need.\n\nTorque Teno Virus (TTV), a non-pathogenic virus with a high prevalence worldwide, has emerged as a promising biomarker in this context. Its replication inversely reflects immune control by T cells, correlating with the depth of therapeutic immunosuppression. Additionally, its slow replication kinetics make TTV DNAemia a useful marker for evaluating patient adherence to immunosuppressive treatments.\n\nThe TAOIST study tests whether longitudinal monitoring of TTV DNAemia every six months, starting from the second year after transplantation, can guide the personalization of immunosuppressive therapy. The primary endpoint is the time to the first occurrence of complications linked to inadequate immunosuppression, including dnDSA, biopsy-proven rejection, infection, cancer, or graft loss. Secondary objectives include evaluating the acceptability of TTV DNAemia among healthcare professionals and assessing its cost-effectiveness compared to standard care. An ancillary objective examines the link between TTV DNAemia and the immunosuppressant possession ratio (IPR) to explore its potential as a marker of treatment adherence.",[256,257,258,29],"Infection","Cancer","Rejection",[260,261,262,263,264],"TTV","Biomarker","immunosuppression","precision medicine","kidney transplantation","2026-05-22",{"date":237,"type":39},{"date":268,"type":39},"2025-04-23",{"date":270,"type":22},"2031-02-02",{"name":272,"class":77},"Hospices Civils de Lyon",4,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":282,"enrollmentInfo":283,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":78},"100638447","muscle-ultrasound-for-sarcopenia-assessment-in-kidney-transplant-recipients-100638447","NCT07607236","Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients","A Prospective Observational Study of Multimodal Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients","KT-SARC","Inclusion Criteria:\n\n* Adult patients aged 18 years or older\n* Patients scheduled to undergo kidney transplantation\n* Ability to undergo muscle ultrasound and bioelectrical impedance analysis (BIA)\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Patients with severe limb deformity or conditions preventing muscle ultrasound assessment\n* Patients with implanted electronic devices contraindicating BIA assessment\n* Inability to complete study assessments","80 Years",{"count":284,"type":22},140,"This is a single-center prospective observational study designed to evaluate the effectiveness of multimodal muscle ultrasound for the assessment of sarcopenia in kidney transplant recipients. Adult patients undergoing kidney transplantation will undergo both muscle ultrasound and bioelectrical impedance analysis (BIA) at predefined time points before and after transplantation.\n\nThe primary objective is to evaluate the diagnostic performance of muscle ultrasound for sarcopenia assessment, including its correlation and agreement with BIA-derived skeletal muscle index (BIA-SMI), as well as its diagnostic accuracy. Secondary objectives include describing the longitudinal changes in sarcopenia prevalence and muscle-related parameters from the pre-transplant period to 1 year after transplantation.\n\nThe study aims to provide evidence for a convenient, noninvasive, radiation-free, and reliable method for sarcopenia assessment in kidney transplant recipients.",[287,29,288],"Sarcopenia","Muscle Wasting",[290,291,292,293,294,126,295],"Muscle Ultrasound","Bioelectrical Impedance Analysis","BIA-SMI","Kidney Transplant Recipient","Muscle Mass","Prospective Cohort","2026-05-19",{"date":206,"type":39},{"date":299,"type":22},"2026-05-30",{"date":301,"type":22},"2028-01-30",{"name":303,"class":77},"Sichuan Provincial People's Hospital",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":18,"minAge":154,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":326,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":78},"100627258","kidney-transplant-improvement-through-new-exercise-training-to-increase-capacity-100627258","NCT07446296","Kidney Transplant Improvement Through New Exercise Training to Increase Capacity","KINETIC -- Kidney Transplant Improvement Through New Exercise Training to Increase Capacity","KINETIC","Inclusion Criteria:\n\n* be at least 60 years old\n* receive transplant care at Penn Medicine\n* be on the kidney transplant waiting list\n* speak and comprehend English\n* be able to walk\n* have at least one physical function limitation OR at least one frailty metric\n* have access to a device capable of connecting to the Internet and downloading an application\n* be able to provide written informed consent\n* be cleared for participant via the Physical Activity Readiness Questionnaire (PARQ) verified against medical record or via written medical clearance from a clinician\n\nExclusion Criteria:\n\n* Have had a myocardial infarction or a stroke in the 3 months immediately prior to enrollment\n* Be unable to self-monitor with study devices (i.e., have a condition such as dementia)\n* Not cleared by PARQ or receive written medical clearance to exercise\n* Participate in another physical activity study\n* Have any other reason they do not expect to be able to complete the study",{"count":313,"type":22},60,[90],"The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants.\n\nThe main questions it aims to answer are:\n\n* Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list?\n* Do participants follow the exercise program and wear a physical activity tracker as asked?\n* Is the program safe and well tolerated?\n\nResearchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function:\n\n* Usual pre-transplant care with a physical activity tracker\n* Usual pre-transplant care plus an online exercise program\n\nParticipants will:\n\n* Wear a wrist activity tracker to measure daily physical activity\n* Complete a one-week baseline period before being assigned to a study group\n* Be randomly assigned (like flipping a coin) to one of two groups\n* If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback\n* Answer questionnaires about their health, activity, and experience in the study\n\nThis study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.",[317,318,319,320,321,322,29,323,324,325],"Chronic Kidney Disease 5D","Chronic Kidney Disease Stage 5","Kidney Failure","Kidney Failure,Chronic","Renal Insufficiency Chronic","Chronic Kidney Disease Stage 4","Waiting List","Transplant Candidate","Exercise Theraphy",[327,328,329,330,331,332,333],"kidney transplant candidates","prehabilitation","home-based exercise","physical activity program","kidney transplant waiting list","pre-transplant care","physical function","2026-05-05",{"date":336,"type":39},"2026-05-06",{"date":338,"type":39},"2026-03-24",{"date":340,"type":22},"2028-05",{"name":342,"class":77},"University of Pennsylvania",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":18,"minAge":351,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":358,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":78},"100621217","testing-the-feasibility-of-a-self-management-support-program-for-patient-with-chronic-diseases-in-israel-100621217","NCT07367750","Testing the Feasibility of a Self-Management Support Program for Patient With Chronic Diseases in Israel","Implementation of a Self-Management Support Program Among People With Kidney Transplant and Cancer Survivors in Israel: Testing Feasibility and Effects","CDSMP-IL","Inclusion Criteria:\n\n* Age 21 years or older\n* Diagnosed with at least one chronic disease (as documented in the medical record)\n* Community-dwelling\n* Fluent in Hebrew\n\nExclusion Criteria:\n\n* Documented cognitive impairment\n* Diagnosis of major depression or other psychiatric disorder (based on self-report or medical records)\n* Hospitalization in the past 3 months","21 Years",{"count":5,"type":22},[90],"This study explores an intervention to support people in Israel who are living with chronic health conditions such as cancer or after kidney transplantation. It focuses on a well-known international program called the Chronic Disease Self-Management Program (CDSMP), which was developed at Stanford University. The program helps individuals build confidence and skills to better manage their health, feel more in control, and improve their day-to-day quality of life.\n\nParticipants will take part in a six-week group program, delivered online, where they will learn practical strategies for managing symptoms like fatigue or pain, setting achievable health goals, communicating effectively with healthcare professionals, and staying active and engaged. The sessions are guided by trained facilitators and include support from others facing similar health challenges.\n\nThe study will involve surveys before and after the program, as well as a follow-up six months later, to understand how the program may have helped participants. Some participants will also be invited to share their experiences in small discussion groups.\n\nBy testing this program in Israel, the researchers hope to learn how it can be adapted and offered more widely to help others living with chronic conditions.",[356,29,357],"Chronic Disease","Cancer Survivorship",[356,359,360,361,362,363],"Self-Management","CDSMP","Kidney","Transplantation","Cancer Survivors","2026-04-28",{"date":366,"type":39},"2026-04-29",{"date":368,"type":39},"2025-02-01",{"date":370,"type":22},"2027-03-28",{"name":372,"class":77},"University of Haifa",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":78},"100575856","phase-1-eight-treg-studytrial-of-adoptive-immunotherapy-with-autologous-ex-vivo-expanded-regulatory-cd8-t-cells-in-living-donor-kidney-transplant-recipients-100575856","NCT06777719","Eight-Treg Study:Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients","Eight-Treg Study: a Phase I Dose Escalation Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients","Eight-Treg","for kidney transplant recipient: pre-Inclusion Criteria:\n\n1. Man or woman with chronic renal failure requiring kidney transplantation and approved to receive a primary kidney allograft from a living donor.\n2. Weight between 50 and 100 kg.\n3. Up-to-date vaccination against SARS Cov2 depending on the health situation and the rules in force with last recall done at least 6 to 1 month prior to visit 1.\n4. Negative microlymphocytotoxicity (LCT) and flow cytometry crossmatches regardless of HLA compatibility\n5. Signed and dated written informed consent \\*.\n6. Aged at least of 18 years the day the consent is signed.\n7. Able to commence the IS regimen at the protocol-specified time point.\n8. As a precautionary measure, women of childbearing age should use an effective method of birth control, and male participants should use contraception to avoid partner pregnancy for the duration of the trial.\n9. Affiliated or beneficiary of a social security scheme.\n10. Speaking and understanding French.\n\nInclusion Criteria:\n\n1. WOCBP must have a negative serum pregnancy test.\n2. Respects the following conditions:\n\n   * Condition 1: number of CD8+ Tregs \u002F ml of blood \\> 2.096x106 CD8+ Tregs \u002F weight\n   * Condition 2 (depending on the dose level considered):\n\n     * Dose 1: number of CD8+ Tregs \u002F ml of blood \\> 1.15x104 CD8+ Tregs + 3.18x103 CD8+ Tregs \u002F weight\n     * Dose 2: number of CD8+ Tregs \u002F ml of blood \\> 4.6x104 CD8+ Tregs + 3.18x103 CD8+ Tregs \u002F weight\n     * Dose 3: number of CD8+ Tregs \u002F ml of blood \\> 9.22x104 CD8+ Tregs + 3.18x103 CD8+ Tregs \u002F weight\n\nPre-Exclusion Criteria:\n\n1. Patient has previously received any tissue or organ transplant other than the planned kidney graft.\n2. Genetically identical to the prospective organ donor at the HLA loci.\n3. Known contraindication to the protocol-specified treatments \u002F medications or components used in the manufacture of the experimental drug.\n4. Presence of donor-specific antibodies (DSA) detected prior transplantation determined by Luminex within 3 months or presence of cytotoxic DSA determined by cell-based CDC assay.\n5. Previous treatment with any desensitisation procedure (with or without IVIg).\n6. Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal \u002F squamous cell carcinoma of the skin).\n7. ABO incompatibility\n8. Evidence of significant local or systemic infection on visit 1.\n9. Malignant or pre-malignant haematological conditions.\n10. Ongoing treatment with systemic IS drugs at visit 1 (except corticoids \\\u003C 10 mg).\n11. Any vaccine (or vaccine recall) dated within 3 months on visit 1 except the SARS Cov2\\*.\n12. Participation in another clinical trial during the study or within 28 days prior to the planned study entry and \u002F or exposure to an investigational product during the study or within 28 days prior to the planned study entry (date of signature of the consent collection form).\n13. Women who are pregnant (or planning to be during the course of the study) or breastfeeding or women with a positive pregnancy test on enrolment (visit 1, screening failure).\n14. Psychological, familial, sociological or geographical factors that potentially hampering compliance with the study protocol and follow-up visit schedule.\n15. Any form of drug abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may invalidate communication with the investigator and\u002For designated study personnel.\n16. Any pro-coagulant disposition, as evidences by a past history of thromboembolic disease or abnormal laboratory coagulation parameters which, in the judgement of the investigator, would place the subject at undue risk.\n17. Any condition resulting in a substantial reduction in the volume of the pulmonary vasculature or an increase in the pulmonary vascular resistance. Any disease or disease process leading to substantially elevated pulmonary arterial pressure (as evidences by electrocardiography, echocardiography, radiology or cardiac catheterization) or right heart hypertrophy or dysfunction.\n18. Known atrial or ventricular septal defects posing a risk of paradoxical embolism of infused cells or cell aggregates.\n19. Patients unable to freely give their informed consent (e.g. patients under guardianship, curatorship, protection of justice).\n20. Patients deprived of their liberty.\n\nExclusion Criteria:\n\n1. Human Immunodeficiency Virus (HIV)-positive, Epstein-Barr Virus (EBV)-negative (if donor is EBV positive), HTLV positive, syphilis-positive serology or suffer from chronic viral hepatitis.\n2. Significant liver disease, defined as persistently elevated Aspartate Transaminase (AST) and \u002F or Alanine Transaminase (ALT) levels \\> 2 x upper limit of normal range.\n\nDonor:\n\nPre-Inclusion Criteria:\n\n1. Willing and able to provide a blood and an urine sample for the immune monitoring.\n2. Willing to provide personal and medical\u002Fbiological data for the trial analysis.\n3. Signed and dated written informed consent \\*.\n4. Aged at least of 18 years the day the consent is signed.\n5. Affiliated or beneficiary of a social security scheme.\n6. Speaking and understanding French.","99 Years",{"count":383,"type":22},9,[158],"The only curative treatment for end-stage renal disease is through kidney transplantation. Solid organ transplants success had been made possible by the development of Immunosuppressive (IS) drugs. However, the long-term survival of transplants is still shortened by the chronic dysfunction of the graft which is not prevented by current IS regimens. Moreover, these IS drugs increase the risk of opportunistic infections and malignancies, and have many non-immune side-effects that hamper their tolerability.\n\nNew research strategies are, therefore, developed with the aim of reducing the dependence on conventional pharmacological IS drugs. Regulatory cell therapy is one of these strategies. It consists of expanding specific populations of immune regulatory cells ex vivo into cell-based drugs that can then be infused into transplant recipients, with the goal of inducing graft tolerance.\n\nThis is the framework of this clinical trial. The experimental drug \"Eight Treg\" being evaluated in this study is an autologous cell therapy product containing CD8+ regulatory T lymphocytes (Tregs) expanded ex vivo during 21 days of cell culture. Team 2 of the Center for Research in Transplantation and Translational Immunology (CR2TI), Nantes University, INSERM, Mixed Research Unit (UMR) 1064, responsible for developing the manufacturing process of the experimental drug \"Eight Treg\", has demonstrated the feasibility of the expansion of CD8+ Tregs ex vivo and their ability to prevent skin graft rejection and inhibit Graft Versus Host Disease (GVHD) in NOD-Scid-IL-2γ-\u002F- mouse models (NSG)14.\n\nBased on the preclinical experience of CR2TI team 2, which has been working on basic and translational aspects of CD8+ Tregs for 15 years, the present phase I clinical trial aims to assess the safety of increasing doses of the experimental drug \"Eight Treg\" in 9 recipients of renal transplantation from a living donor. The possibility of manufacturing the experimental drug \"Eight Treg\" at the required doses, in accordance with the Good Manufacturing Process (GMP), has been assessed in validation runs as specified at the end of the \"justification of the study\" part of this protocol. This clinical trial will be the first administration of expanded CD8+ Tregs into humans, and it follows previous studies which evaluated the safety of other regulatory cell therapy products, containing expanded CD4+ Tregs and other regulatory cells (autologous tolerogenic dendritic cells performed by Nantes CHU laboratory and clinical services, for example), injected into patients in different contexts (renal transplantation, liver transplantation, GVHD, type 1 diabetes, etc) without causing any significant adverse effect. This study will pave the way for future, broader research on the use of CD8+ Tregs as a possible anti-rejection and tolerance inducer \"drug\" in transplantation.",[29],[99,388,389,390],"living donor kidney","immunotherapy","CD8+ T cells",{"date":366,"type":39},{"date":393,"type":39},"2025-03-03",{"date":395,"type":22},"2027-05-18",{"name":397,"class":77},"Nantes University Hospital",{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":406,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":430},"100558519","phase-2-regulatory-t-cell-therapy-to-achieve-immunosuppression-reduction-100558519","NCT06552169","REgulatory T Cell Therapy to Achieve Immunosuppression REduction","The RETIRE Trial: A Randomized Phase 2 Trial of Adoptive Therapy With Treg Adoptive Cell Transfer (TRACT) To Prevent Rejection in Living Donor Kidney Transplant Recipients","RETIRE","Inclusion Criteria\n\nAll inclusion criteria must be met prior to randomization.\n\n1. Males or females aged 18-65 years as of the date of informed consent who will undergo a single organ, living donor kidney transplant.\n2. Donor aged 18-65 years as of the date of organ donation. A certain degree of HLA matching between the donor and the recipient is not required.\n3. Blood type compatibility between recipient and donor must be established as follows.\n\n   Recipient A to Donor A or O; Recipient B to Donor B or O; Recipient AB to Donor A, B, AB, or O; Recipient O to Donor O.\n4. No prior organ transplant of any kind.\n5. Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the trial. A list of the medically acceptable methods of contraception are listed in the informed consent document.\n6. Male patients must agree to use birth control following the initiation of standard-of-care immunosuppression and for a minimum of 6 months following kidney transplant.\n7. Subjects (recipients) must be able to understand the consent form and give written informed consent prior to any trial procedure.\n8. If donor informed consent is required by IRB\u002FIEC, donor must be able to understand the consent form and give written informed consent prior to any trial procedure. Note: Donor informed consent is required for donors participating in the research assay collections.\n\nExclusion Criteria Based on SOC Pre-Transplant Evaluation\n\nThe following exclusion criteria must be determined prior to randomization per SOC pre-transplant evaluation.\n\n1. Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, or tacrolimus or other immunosuppression medication prescribed.\n2. Subjects with a positive crossmatch by virtual cross matching or complement-dependent cytotoxicity (CDC) cross matching or flow cytometry cross matching (FCXM).\n3. Subjects with PRA \\>80% per SOC pre-transplant assessment. PRA must be repeated prior to transplant if patient receives a blood product transfusion after the initial assessment.\n4. Subjects with current or historic donor specific antibodies.\n5. Body Mass Index (BMI) of \\\u003C 16 kg\u002Fm2 or \\> 38 kg\u002Fm2 per SOC pre-transplant evaluation.\n6. Subjects who are pregnant or nursing mothers.\n7. Subjects whose life expectancy is severely limited by diseases other than renal disease, per judgement of an investigator.\n8. Ongoing active drug or alcohol substance abuse, per judgement of an investigator.\n9. Major ongoing psychiatric illness or recent history of noncompliance with current medical therapy, per judgement of an investigator.\n10. Significant cardiovascular disease (e.g.):\n\n    * Significant non-correctable coronary artery disease, per judgement of an investigator\n    * Ejection fraction below 30% per SOC echocardiogram if an echocardiogram is performed for an individual subject as part of their pre-transplant evaluation\n    * History of recent (\\\u003C 12 months) myocardial infarction at time of informed consent\n    * History of recent (within 3 months) vascular intervention(s) for coronary artery disease at the time of informed consent\n    * Documented arrhythmias that require a pacemaker or medical therapy for control.\n11. Subjects who require use of chronic anticoagulation medications. Use of anti-platelet medications will be allowed in absence of a documented arrhythmia.\n12. Malignancy within 3 years, excluding non-melanoma skin cancers such as basal cell carcinoma and squamous cell carcinoma.\n13. Serologic evidence of active infection with HCV, HIV or HBV per SOC pre-transplant evaluation. Historical data within three months of transplant are acceptable.\n14. Subjects with a total white blood cell count \\\u003C 4,000\u002Fmm3; platelet count \\\u003C 50,000\u002Fmm3; triglyceride \\> 400 mg\u002FdL; total cholesterol \\> 300 mg\u002FdL, prothrombin time \\\u003C8.4 seconds or \\>15.7 seconds, activated partial thromboplastin time \\\u003C21.6 or \\> 42.3 seconds, fibrinogen \\\u003C177 mg\u002FdL or \\>598 mg\u002FdL, and INR \\\u003C0.64 or \\>1.4.\n15. Subjects with underlying renal disease etiologies with high risk of disease recurrence such as primary focal segmental glomerulosclerosis and others per investigator discretion.\n16. Subjects requiring the use of chronic immunosuppressive medication to control an underlying renal disease, or a disease with extrarenal manifestations (i.e., inflammatory bowel disease). Subjects requiring chronic or intermittent use of inhaled corticosteroids for respiratory conditions will be allowed.\n17. Diabetic subjects with an HbA1c of \\>8%.\n\n    The following exclusion criteria must be determined prior to transplant per SOC pre-transplant evaluation.\n18. Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to transplant.\n\nExclusion Criteria Prior to Leukapheresis (Arm 2)\n\n1. Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to leukapheresis.\n2. Subjects with PRA \\>80%, if repeated after SOC pre-transplant assessment. (PRA must be repeated prior to leukapheresis if patient receives a blood product transfusion after the initial assessment).\n3. Subjects who are pregnant or nursing.\n4. Subjects who received an investigational drug within 30 days prior to leukapheresis.\n5. Subjects who received anti-T cell therapy within 30 days prior to leukapheresis.\n6. Subjects who do not meet pre-leukapheresis clearance parameters per institutional practices or per investigator discretion.\n\nExclusion Criteria Prior to TRACT Cellular Product Infusion (Arm 2)\n\n1. Subjects with an active infection considered clinically significant by the investigator that has not resolved prior to planned Treg infusion.\n2. Subjects with a new, clinically significant medical condition that, per investigator opinion, would impact the ability to safely administer TRK-001.\n3. Subjects who experience a rejection episode of the kidney graft prior to the planned Treg infusion.\n4. Subjects who are pregnant or nursing. Women who are of childbearing potential must have a negative urine or serum pregnancy test before infusion of TRK-001.\n5. Subjects who received an investigational drug within 30 days prior to infusion.\n6. Subjects who received anti-T cell therapy within 30 days prior to infusion.","65 Years",{"count":408,"type":22},34,[25],"The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients.\n\nEnrolled subjects will be randomized to one of 2 study arms:\n\nArm 1 subjects will receive standard of care immunosuppression\n\nArm 2 subjects will receive initial standard of care (SOC) immunosuppression and a single infusion of TRK-001. Three months after the transplant, Arm 2 subjects may be able to begin reducing their immunosuppression medication to a 1-drug regimen.\n\nThe primary outcome measures of trial are to evaluate several components indicating immunologic problems with the transplanted organ at 1-year post-transplant and to evaluate the ability for the study subjects given TRK-001 to wean to a 1-drug immunosuppression regimen.\n\nAll enrolled subjects will be followed for 5 years post-transplant.",[29],[413,414,29,415,416,417,418,419,420],"Regulatory T cells","Treg adoptive cell transfer (TRACT)","Graft Rejection","Autologous cell therapy","End stage renal disease","Prevention of organ transplant rejection","Tregs","Reduced immunosuppression","2026-04-22",{"date":423,"type":39},"2026-04-27",{"date":425,"type":39},"2025-06-13",{"date":427,"type":22},"2031-12",{"name":429,"class":46},"Singulera Therapeutics Inc.",7,{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":437,"sex":18,"minAge":19,"maxAge":193,"enrollmentInfo":438,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":78},"100241458","mri-technical-development-and-applications-in-kidney-disease-100241458","NCT02421497","MRI Technical Development and Applications in Kidney Disease","For Specific Aim 1: MRI Technical Development Studies\n\nInclusion Criteria:\n\n1\\. Healthy Volunteer\n\nExclusion Criteria:\n\n1. Ferromagnetic implants\n2. Any foreign metal objects in the body\n3. History of shrapnel or shot gun injury\n4. Cardiac pacemakers\n5. Defibrillator\n6. Neuronal stimulator\n7. Magnetic aneurysm clip\n8. Large tattoos on the abdomen or the brain and neck\n9. Hip replacement\n10. Too large to fit in the magnet (body mass index \\>= 40, approx.)\n11. Severe claustrophobia\n12. Women with pregnancy\n\nFor Specific Aim 2: Pilot Studies with Patients\n\nStudies for CKD\n\nInclusion\n\n1. English- speaking as primary language.\n2. Age 45 years and older\n3. Able to complete an approximately 90 minute cognitive testing battery.\n4. Able to sign the informed consent, or allow a caregiver, relative, surrogate, or witness to sign the informed consent if participant is unable to do so.\n5. GFR \\\u003C 90 ml\u002Fmin\u002F1.73m2\n\nExclusion\n\n1. Acute psychiatric illness that would impede cognitive testing\n2. Active chemical dependence, such as alcohol, narcotics or other drugs\n3. Legally blind or unable to complete cognitive tests due to visual loss or deafness\n4. Dialysis dependent or renal transplant recipient at time of screening or baseline\n5. Chronic obstructive pulmonary disease\n6. Severe CI unable to complete the Modified Mini-Mental State Examination \\[3MSE\\]\n\nStudies for Renal Transplantation\n\nInclusion\n\n1. Able to sign the informed consent, or allow a caregiver, relative, surrogate, or witness to sign the informed consent if participant is unable to do so.\n2. Age 45 years and older\n\nExclusion\n\n1. Not on dialysis due to allograft failure\n2. Chronic obstructive pulmonary disease",true,{"count":439,"type":22},180,"Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to:\n\n1. develop, customize, and optimize anatomic and functional MRI methods,\n2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and\n3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.\n\nIn addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.",[442,29,96,443],"Chronic Kidney Diseases","Cognition Disorders","2026-04-09",{"date":446,"type":39},"2026-04-13",{"date":448,"type":22},"2028-06-30",{"date":450,"type":22},"2029-12-30",{"name":452,"class":77},"University of Minnesota",{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":193,"enrollmentInfo":460,"targetDuration":4,"studyType":23,"phases":462,"briefSummary":464,"conditions":465,"keywords":468,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":273},"100372345","phase-3-shingrix-in-renal-transplant-recipients-100372345","NCT04128189","Shingrix in Renal Transplant Recipients","Safety and Immunogenicity of Shingrix in Renal Transplant Recipients","Study Population:\n\nAdults with chronic kidney failure who are listed for kidney transplantation at participating transplant centers.\n\nInclusion Criteria:\n\nAge 18 to 70 years Able and willing to provide written informed consent Currently on the waiting list for kidney transplantation at a participating institution, with anticipated transplantation occurring between \\>3 and 24 months after the first dose of Shingrix\n\nEither:\n\nEligible to receive Shingrix at study entry per CDC-recommended schedule, or Previously completed the Shingrix vaccination series within 3 to 24 months prior to study entry Female participants of non-childbearing potential (e.g., tubal ligation, hysterectomy, ovariectomy, or post-menopausal ≥12 months)\n\nFemale participants of childbearing potential must:\n\nUse adequate contraception for at least 30 days prior to vaccination Have a negative pregnancy test on the day of each vaccination Agree to continue adequate contraception during the study and for 2 months after completing the vaccination series Be considered by the investigator likely to comply with study requirements\n\nExclusion Criteria:\n\nActive immunosuppressive or immunodeficient condition (e.g., malignancy, HIV infection) or receipt of immunosuppressive therapy within 3 months prior to planned vaccination that, in the investigator's opinion, may interfere with vaccine response History of herpes zoster (shingles) within the past 3 years Receipt of varicella vaccine within 3 years prior to study entry Known allergy to any component of the Shingrix vaccine Receipt of investigational drugs within 30 days prior to enrollment or planned use during the study Receipt of non-live vaccines within 2 weeks prior to any Shingrix dose or planned within 30 days after vaccination Receipt of live vaccines within 4 weeks prior to any Shingrix dose or planned within 30 days after vaccination Pregnant or breastfeeding Planned or prior multi-organ transplantation Residence or travel distance greater than 2 hours from the study site, which would interfere with study visits or timely processing of blood samples",{"count":461,"type":22},132,[463],"PHASE3","The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection.\n\nThe main questions it aims to answer are:\n\nHow strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant?\n\nDoes a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose?\n\nHow long does protection from the vaccine last before and after transplant?\n\nHow safe is the vaccine in this group, including whether it affects transplant-related immune markers?\n\nResearchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection.\n\nParticipants will:\n\nBe screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining\n\nIf they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose\n\nComplete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits\n\nTake part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research\n\nShingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.",[466,319,125,29,467],"Kidney Transplant Recipient Response to Shingrix Vaccine","Herpes Zoster (HZ)",[469,470,471,472,473,319,474,475,476,477,478,479,480,481,482,483,484,485,486,487],"Shingrix","Recombinant Zoster Vaccine","Herpes Zoster Vaccine","Herpes Zoster","Shingles","Chronic Kidney Disease","Renal Failure","Kidney Transplant","Renal Transplantation","Transplant Candidates","Immunocompromised","Immunogenicity","Vaccine Response","Cellular Immunity","T Cell Response","Booster Dose","Vaccine Durability","Post-Transplant Immunity","Vaccine Safety","2026-04-02",{"date":490,"type":39},"2026-04-08",{"date":492,"type":39},"2023-03-02",{"date":494,"type":22},"2029-06",{"name":496,"class":77},"University of Colorado, Denver",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":224,"maxAge":193,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":518},"100583610","phase-1-study-to-evaluate-the-safety-and-efficacy-of-the-10-ge-xenokidney-in-patients-with-esrd-100583610","NCT06878560","Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD","EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (ESRD)","EXPAND","Inclusion Criteria for all Participants (Groups 1 and 2):\n\n1. Provide voluntarily informed consent to participate in the study and for lifetime follow up.\n2. Have a diagnosis of ESRD at the time of informed consent.\n3. Hemodialysis dependent for a minimum of 6 months and has a functioning arterial venous fistula\u002Fgraft or permanent catheter at the time of informed consent.\n4. 50 to 70 years of age at the time of informed consent, or 40 to \\\u003C50 years of a age with a calculated panel reactive antibody (cPRA) of ≥99.9%.\n5. Live withing 3 hours travel time of the xenotransplant center.\n6. Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth control, if the possibility of conception exists.\n7. Negative xeno-crossmatch at Screening and pre-transplant.\n8. Estimated Post Transplant Survival Calculator score \\>20% (https:\u002F\u002Foptn.transplant.hrsa.gov\u002Fdata\u002Fallocation-calculators\u002Fepts-calculator\u002F).\n9. Body mass index ≤35 kg\u002Fm2.\n10. Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention recommended courses of age and risk factor appropriate vaccinations.\n11. Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.\n\nAdditional Inclusion Criteria for Group 1:\n\n1\\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:\n\n1. Ineligible for a living donor transplant.\n2. Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).\n3. Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).\n\nAdditional Inclusion Criteria for Group 2:\n\n1. On an OPTN kidney transplant waitlist (active or inactive status).\n2. No approved living kidney donors.\n3. More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for \"Choose your state\" field and National average for \"Choose your transplant program\" field; https:\u002F\u002Fwww.srtr.org\u002Ftools\u002Fkidney-transplant-decision-aid\u002F).\n\nExclusion Criteria (pertain to all participants in Groups 1 and 2):\n\n1. Need for multiple organ transplants.\n2. Severe medical co-morbidities including, but not limited to:\n\n   1. Chronic liver disease.\n   2. Advanced cardiovascular disease.\n   3. Severe peripheral vascular disease that limits technical ability to transplant the 10 GE Xenokidney.\n   4. Severe neurologic diseases or conditions that would preclude meaningful recovery or informed consent.\n   5. Oral steroid-dependent airway disorder or chronic pulmonary disease or requires chronic, intermittent or continuous supplemental oxygen.\n   6. Pulmonary hypertension.\n   7. Uncontrolled diabetes or sequelae of diabetes mellitus including severe non-proliferative diabetic retinopathy.\n   8. Severe neurogenic bladder that requires intermittent catheterization.\n3. ESRD due to hereditary or structural kidney disease.\n4. Active or recently treated malignancy at the time of informed consent.\n5. Non-renal cause of hematological disorders associated with anemia (eg, thalassemia and sickle disease).\n6. Cannot discontinue chronic anticoagulation therapy (low-dose daily aspirin is permissible).\n7. History of major psychiatric disorders with a psychiatric hospitalization and\u002For suicidal ideation within 5 years of informed consent.\n8. Being treated for active tuberculosis (TB), have received prophylaxis for positive FDA-approved interferon-gamma release assay, or test positive for TB by FDA-approved interferon-gamma release assay test during Screening.\n9. Nucleic acid test (NAT) positive for hepatitis B virus and\u002For hepatitis C virus, hepatitis B surface antibody (anti HBs) titer \\\u003C10 mIU\u002FmL unless the participant is determined to be a nonresponder to hepatitis B vaccination (a nonresponder is defined as having an anti-HBs titer \\\u003C10 mIU\u002FmL after having completed both the standard vaccine series and a fourth booster dose and\u002For second standard vaccine series), and\u002For positive for human immunodeficiency virus (HIV; HIV-1 and HIV-2 antibody and\u002For NAT).\n10. Not able to independently perform activities of daily life.\n11. Have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation (eg, history of substance use disorder (SUD) within 1 year of informed consent, lack of social support, untreated psychological conditions).",{"count":226,"type":22},[158,25],"The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2).\n\nThe study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.",[230,29,231],[510,233,234,231],"10 GE Xenokidney",{"date":512,"type":39},"2026-03-27",{"date":514,"type":39},"2025-10-29",{"date":516,"type":22},"2075-10",{"name":242,"class":46},2,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":437,"sex":18,"minAge":527,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":539,"leadSponsor":541,"locationsCount":543},"100559777","phase-4-reduced-immunosuppression-in-older-renal-transplant-recipients-with-trugraftrac-monitoring-riot-trial-a-prospective-randomized-multicenter-trial-100559777","NCT06568549","Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®\u002FTRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.","Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf® Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.","RIOT","Inclusion Criteria:\n\n* Solitary kidney transplant recipient \\>55 years of age. At most 1 prior solitary kidney transplant.\n* No other solid organ transplant though recipients of autologous stem cell transplants are eligible.\n* HIV negative.\n* Subjects must be on tacrolimus and mycophenolate mofetil or Myfortic at the time of consent. Prednisone at the time of consent is optional and is per local standard of care. Patients randomized to MMF withdrawal will be placed on prednisone 5mg\u002Fd at 4 months. Use of other immunosuppression medications for maintenance (cyclosporine, azathioprine, belatacept, sirolimus) is excluded.\n\nExclusion Criteria:\n\nTime of Transplant Exclusion Criteria:\n\n* The results of the most recent DSA testing indicate DSA with an MFI \\>2000.\n* The results of the most recent cPRA testing indicate cPRA is above \\>80% (based on MFI \\>2000).\n\n  4-Month Exclusion Criteria:\n* Acute rejection episode either clinical or on biopsy (greater than borderline). Subjects must not experience any type of rejection episodes from the time of transplant and must not show any signs of rejection (Cellular or Antibody mediated rejection, excluding borderline) at their 4-month biopsy (If obtained per standard of care). Subjects experiencing rejection will not be eligible for randomization and MMF withdrawal.\n* De novo DSA\n* Subjects who are not on tacrolimus at the time of randomization will be placed in the non-randomized group.\n* Subjects who at the time of or prior to randomization were maintained on mycophenolate mofetil or Myfortic and have had their medication held or temporarily discontinued due to clinical indications (toxicity to the medication, polyoma virus infections, cancer, etc.) remain eligible for randomization.\n* Has a history of an underlying clinically significant acute or chronic medical condition or physical examination findings which, in the opinion of the investigator, would make study participation not in the participants best interest (e.g., compromise the well-being) or that could prevent, or limit the protocol-specified assessment.","55 Years",{"count":529,"type":22},350,[197],"The purpose of this research is to determine the safety and efficacy of withdrawing MMF (Mycophenolate Mofetil) in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant. We are comparing them to patients who receive the standard of care Mycophenolate Mofetil.",[29,533],"Mycophenolate Mofetil",[476],"2026-03-18",{"date":537,"type":39},"2026-03-20",{"date":425,"type":39},{"date":540,"type":22},"2031-03-31",{"name":542,"class":77},"Mayo Clinic",3,{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":23,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":273},"100429312","impact-of-extracorporeal-phototherapy-ecp-on-auxiliary-follicular-t-lymphocytes-and-circulating-b-lymphocytes-during-chronic-antibody-mediated-rejection-in-kidney-transplantation-100429312","NCT04870437","Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.","Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation: IPECAM","IPECAM","Inclusion Criteria:\n\n* ECP treatment decision based on transplant team habits (care management)\n* Age ≥ 18 years\n* Affiliation to a French social security scheme\n* Kidney transplant at least 6 months prior to inclusion\n* cABMR proven by a renal graft biopsy less than 3 months and meeting the following histological criteria:\n\n  * allograft glomerulopathy (cg\\>0, and maximum score cg2) or intimal fibrosis\n  * C4d positive or ptc+g greater than or equal to 2\n  * Presence of Donor Specific Antibody (DSA)\n  * Interstitial Fibrosis and Tubular Atrophy (IFTA) less than or equal to 2\n* Glomerular filtration rate \\> 30 mL\u002Fmin\u002F1.73 m2\n* Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* Active infection or infection with hepatitis B, C or HIV virus\n* Pregnant, breastfeeding or parturient woman\n* Person deprived of liberty by judicial or administrative decision\n* Person receiving psychiatric care under duress\n* Person subject to legal protection\n* Person out of state to express consent",{"count":553,"type":22},30,[90],"Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring.\n\nExtracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft.\n\nThe mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated.\n\nThe hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.",[29],[558,559,29],"Chronic AntiBody-Mediated Rejection","ExtraCorporeal Phototherapy","2026-03-04",{"date":562,"type":39},"2026-03-06",{"date":564,"type":39},"2022-04-27",{"date":566,"type":22},"2026-10-27",{"name":568,"class":215},"University Hospital, Angers",{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":193,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":579,"conditions":580,"keywords":584,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":78},"100620938","kidney-transplant-immunosuppressive-therapy-adherence-trial-kite-100620938","NCT07364123","Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE)","Education and Telephone Counseling to Improve Adherence to Immunosuppressive Medication in Kidney Transplant Recipients: A Randomized Controlled Trial","KITE","Inclusion Criteria:\n\n* Adult kidney transplant recipients aged 18 years or older\n* At least 1 month post-kidney transplantation\n* Able to provide informed consent\n* Cognitively intact and oriented to person, place, and time\n* Able to communicate via telephone\n* Voluntarily willing to participate in the study\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Severe cognitive impairment preventing participation\n* Inability to communicate effectively (hearing or speech limitations without support)\n* Patients who do not meet the post-transplant time threshold (less than 1 month)\n* Patients unwilling or unable to participate in follow-up sessions",{"count":313,"type":22},[90],"This randomized controlled interventional study aims to evaluate the effect of structured education and telephone counseling on immunosuppressive medication adherence among kidney transplant recipients. Poor adherence to immunosuppressive therapy after kidney transplantation is a major risk factor for acute rejection, graft loss, and increased morbidity. Education and behavioral support interventions delivered by nurses may improve medication understanding, adherence behaviors, and self-management skills.\n\nIn this trial, 60 participants will be randomly assigned to either an intervention group receiving individualized education, an immunosuppressive medication adherence booklet, and scheduled telephone counseling sessions, or a control group receiving routine clinical care. Adherence will be assessed using the Immunosuppressive Medication Adherence Scale and biological monitoring through tacrolimus level variability over 8 weeks. Additional outcomes include changes in medication knowledge scores based on pre-test and post-test assessments.\n\nThe study will contribute evidence regarding whether nurse-led telephone counseling and structured education can enhance adherence, improve clinical follow-up, and support long-term graft success in kidney transplant patients.",[29,581,582,583],"Medication Non-Adherence","Immunosuppressive Therapy","Renal Transplant Recipients",[476,585,586,587,588,589],"Immunosuppressive Medication","Medication Adherence","Telephone Counseling","Patient Education","Tacrolimus Levels","2026-01-26",{"date":592,"type":39},"2026-01-28",{"date":594,"type":22},"2026-01-05",{"date":596,"type":22},"2026-08-15",{"name":598,"class":77},"University of Gaziantep",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":606,"targetDuration":608,"studyType":122,"phases":4,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":624},"100622156","imlifidase-for-highly-sensitized-kidney-transplant-recipients-with-a-positive-crossmatch-against-a-deceased-donor-results-of-kidney-transplantations-performed-in-accordance-to-the-french-guidelines-100622156","NCT07379957","Imlifidase for Highly Sensitized Kidney Transplant Recipients With a posItive crossmAtch Against a Deceased Donor: Results of Kidney Transplantations Performed in Accordance to the French Guidelines.","ISKIA","Inclusion Criteria:\n\n* Highly sensitized adult kidney transplant candidates\n* Eligible to imlifidase (patient with a delisting of at least one A, B, DR, DQ HLA antibody)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years-old",{"count":607,"type":22},450,"36 Months","Imlifidase is a recombinant cysteine protease derived from Streptococcus pyogenes and produced in Escherichia coli, which has the ability to cleave and degrade all human IgGs. Four to six hours after imlifidase infusion, the entire IgG pool is degraded into F(ab')2 and Fc fragments. In vitro, imlifidase inhibits HLA antibody-mediated NK cell activation and antibody-dependent cell-mediated cytotoxicity. Imlifidase degrades also the IgG of the B cell Receptor (BCR), inhibiting BCR-mediated cell signal, transiently preventing memory B cell response to antigenic stimulation and their transition into antibody-producing cells.\n\nTwo clinical studies have been designed to determine whether imlifidase could inactivate IgG donor-specific antibodies as a desensitization strategy in highly sensitized candidates for kidney transplantation. In the phase I\u002FII study, 25 patients were transplanted in Sweden and United States. Among them, 18 had a positive flow cytometry crossmatch (FCXM) and 2 a positive complement-dependent cytotoxicity crossmatch (CDCXM). In the phase II study (Highdes Trial), 19 patients with an incompatible living or deceased donor from the United States, Sweden, and France were included. Among them, 7, 18, 2, and 8 had respectively a positive T-cell FCXM, positive B-cell FCXM, positive T-cell CDCXM, and positive B-cell CDCCXM. The primary efficacy endpoint was the ability of Imlifidase to convert a positive XM to a negative one. Conversion of baseline positive XM to negative within 24 h after Imlifidase treatment occurred in 89.5% (n=17) of the 19 patients. In the follow-up study including all the patients transplanted after Imlifidase desensitization, the antibody-mediated rejection rate (AMR) was at 39%, most of them occurring during the first month post-transplantation. Three-year death-censored graft survival was 93% in patients with AMR and 77% in the others. Three-year patient survival was 85% in patients with AMR and 94% in the others. No safety signal was reported.\n\nBased on these data, Imlifidase is now indicated as a desensitization agent of highly sensitized adult kidney transplant patients with positive crossmatch against an available ABO-compatible deceased donor. It should be reserved for patients unlikely to be transplanted under the available kidney allocation system including the prioritization program for highly sensitized patients (https:\u002F\u002Fwww.ema.europa.eu). Therefore, the French Society of Transplantation (SFT), the French-speaking Society of Nephrology, Dialysis and Transplantation (SFNDT) and the French Society of Histocompatibility and Immunogenetics (SFHI) have proposed French recommendations for patient selection, choice of antibodies characteristics, treatment and follow-up in order to homogenize practices.\n\nAlthough this new treatment addressed an unmet medical need, its authorization was based on only two small-scale studies. Therefore, additional data on long-term graft function and survival are required in patients treated by imlifidase.",[29],[233,612,613,614],"kidney transplant rejection","recombinant cysteine protease derived from Streptococcus pyogenes","imlifidase","2026-01-23",{"date":617,"type":39},"2026-02-02",{"date":619,"type":22},"2026-01",{"date":621,"type":22},"2029-02",{"name":623,"class":77},"University Hospital, Bordeaux",20,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":406,"enrollmentInfo":632,"targetDuration":4,"studyType":23,"phases":633,"briefSummary":634,"conditions":635,"keywords":637,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":4},"100621938","tubeless-spontaneous-ventilation-anesthesia-in-kidney-transplantation-100621938","NCT07377123","Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation","Application of Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation Surgery: A Single-Center, Prospective, Randomized Controlled Trails","Inclusion Criteria:\n\n1. No gender restriction, age 18-65 years (including upper and lower limits).\n2. First-time recipient of citizen organ donation kidney transplantation.\n3. Type of citizen organ donation must be Category I China (Donation after Brain Death DBD).\n4. Donor and recipient blood type identical.\n5. Panel reactive antibody (PRA) results negative within six months preoperatively.\n6. Body mass index (BMI) \\\u003C28 kg\u002Fm².\n7. No severe pulmonary ventilation or gas exchange dysfunction, preoperative pulmonary function assessment meets kidney transplantation requirements, preoperative chest CT shows no significant abnormalities.\n8. No severe arrhythmia (frequent atrial fibrillation or ventricular premature beats), normal cardiac function (ejection fraction \\> 50%).\n9. American Society of Anesthesiologists (ASA) physical status classification ≤ III.\n10. Voluntarily participate in clinical research, fully understand this study and voluntarily sign the informed consent form, and complete all trial procedures.\n\nExclusion Criteria:\n\n1. Combined multi-organ transplantation.\n2. Previous history of organ transplantation other than kidney.\n3. Living donor kidney transplantation.\n4. If one of the two patients receiving a kidney from the same donor does not meet the inclusion criteria, the other patient is also excluded.\n5. Previous history of mental illness, current psychological assessment does not meet transplantation criteria.\n6. Other situations where the organ transplant physician assesses the patient as not suitable for transplantation.\n7. Poor compliance of the recipient or other situations deemed by the researcher as unsuitable for inclusion in the trial.",{"count":313,"type":22},[90],"The aim of this clinical trial is to compare the intraoperative use of neuromuscular blocking agents and other anesthetic drugs between tubeless spontaneous ventilation anesthesia (TSVA) and conventional endotracheal intubation (ETT) anesthesia in kidney transplantation. The study will also evaluate the safety, stability, and postoperative recovery associated with TSVA.\n\nThis trial is designed to address the following questions:\n\n* Does TSVA reduce the intraoperative requirement for neuromuscular blocking agents and other anesthetic medications?\n* Does TSVA improve postoperative outcomes in kidney transplant recipients?\n* How do the intraoperative safety and stability of TSVA compare with those of ETT anesthesia?\n\nResearchers will compare anesthetic drug consumption, intraoperative anesthetic performance, and postoperative recovery outcomes between the TSVA and ETT groups to determine whether TSVA can decrease anesthetic drug use and enhance patient recovery.\n\nParticipants will:\n\n* Undergo a complete preoperative assessment\n* Receive kidney transplantation under TSVA or ETT anesthesia, with relevant intraoperative data recorded\n* Receive tubeless postoperative management, with documentation of pain scores, complications, and recovery of graft function\n* Be followed throughout their lifetime after discharge, providing long-term follow-up information",[29,636],"CKD (Chronic Kidney Disease) Stage 5D",[264,638,639,640],"tubeless","ERAS","anesthesia","2026-01-22",{"date":643,"type":39},"2026-01-29",{"date":645,"type":22},"2026-01-12",{"date":647,"type":22},"2027-12-31",{"name":649,"class":77},"Jianxing He",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":23,"phases":659,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":518},"100614133","phase-1-the-effects-of-vonoprazan-fumarate-on-dgf-incidence-in-dd-kidney-transplant-recipients-100614133","NCT07275632","The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients","A Multicenter, Single-Arm, Exploratory Study Evaluating the Effect of Perioperative Oral Vonoprazan Fumarate on the Incidence of Delayed Graft Function in Deceased Donor Kidney Transplant Recipients","Inclusion Criteria:\n\n* Age ≥ 18 years at time of transplantation.\n* Undergoing first-time deceased-donor kidney transplantation.\n* No administration of proton-competitive acid blockers (P-CABs) in the 1 month prior to transplantation.\n* Consent to receive the standard immunosuppressive therapy post-transplantation.\n* Ability and willingness to provide informed consent and comply with study procedures and follow-up.\n* Complete baseline clinical data available.\n\nExclusion Criteria:\n\n* Receiving a living-donor kidney transplant or multi-organ transplantation.\n* Previous history of any solid organ or cellular transplantation (with the exception of corneal transplants).\n* Intraoperative occurrence of hyperacute rejection or confirmed graft non-function (e.g., renal artery thrombosis).\n* Presence of high risk for primary graft non-function (e.g., severe injury to the transplant renal artery).\n* Severe postoperative intestinal obstruction requiring prolonged fasting or inability to take oral medication in perioperative period.\n* Known history of hypersensitivity to vonoprazan fumarate or any of its excipients.\n* Subjects with severe hepatic impairment (Child-Pugh Class C).\n* Concomitant use of strong CYP3A4 inhibitors (e.g., ritonavir, clarithromycin).\n* Current therapy with atazanavir or rilpivirine.\n* Any other condition deemed by the investigator to be inappropriate for study participation (e.g., uncontrolled active infection, severe peptic ulcer, pregnancy or lactation).",{"count":658,"type":22},47,[158,25],"This is an exploratory, multicenter, single-arm study designed to evaluate the efficacy of perioperative Vonoprazan Fumarate in reducing the incidence of Delayed Graft Function (DGF) in deceased-donor kidney transplant recipients. DGF is a common early complication that significantly impacts graft function and long-term transplant survival. This study aims to explore how Vonoprazan Fumarate, a potassium-competitive acid blocker (P-CAB), can potentially improve macrophage phagocytic function, reduce kidney inflammation, and enhance early kidney function recovery.\n\nPatients aged 18 years and older who are undergoing first-time deceased-donor kidney transplantation will be enrolled. Vonoprazan Fumarate will be administered daily starting on the day of transplantation and continuing for seven days post-surgery. The primary endpoint is DGF incidence, while secondary endpoints include kidney function recovery, serum creatinine reduction, estimated glomerular filtration rate, and safety assessments. Adverse events will be monitored, and the study will also explore potential biomarkers for inflammation and graft function.\n\nThe study is expected to provide insights into a potential new therapeutic strategy to reduce DGF and improve early kidney transplant outcomes, potentially benefiting future kidney transplant patients by offering a safer and more effective perioperative treatment option.",[662,29],"Delayed Graft Function","2025-12-17",{"date":665,"type":39},"2025-12-23",{"date":667,"type":39},"2025-12-10",{"date":669,"type":22},"2026-12-31",{"name":671,"class":77},"First Affiliated Hospital of Chongqing Medical University",{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":676,"acronym":677,"eligibilityCriteria":678,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":23,"phases":681,"briefSummary":682,"conditions":683,"keywords":688,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":698,"locationsCount":78},"100612660","salivary-replication-of-bk-virus-in-post-kidney-transplant-100612660","NCT07256470","Salivary Replication of BK Virus in Post-kidney Transplant","BKSAL","Inclusion Criteria:\n\n* kidney transplant recipients\n* age ≥ 18 years\n\nExclusion Criteria:\n\n* age \\\u003C 18 years\n* absence of consent",{"count":680,"type":22},100,[90],"BK virus infection in kidney transplantation can compromise graft function. Current data suggest that BK virus nephropathy results not only from transmission of virus from the donor but also from reactivation of latent virus in the recipient. However, no study has investigated the possibility of respiratory transmission. This study would provide a better understanding of the pathophysiology of BK virus infection in kidney transplant recipients. The investigators would study viral replication of BK virus in saliva, urine and blood of patients who received a kidney transplant at the Amiens University Hospital. For this, the investigators will collect salivary self-collection on the day of the kidney transplant then at 1, 3, 6, 9 and 12 months as well as a urine and blood sample. The investigators will measure BK viral load in these three samples at different times.",[684,685,29,686,687],"BK Virus","Salivary Replication","Nephropathy","DNAemia",[689,690,264,691,687],"BK virus","salivary replication","nephropathy","2025-12-02",{"date":694,"type":39},"2025-12-08",{"date":696,"type":22},"2025-12",{"date":182,"type":22},{"name":699,"class":77},"Centre Hospitalier Universitaire, Amiens",{"id":701,"slug":702,"hasResults":12,"nctId":703,"briefTitle":704,"officialTitle":705,"acronym":706,"eligibilityCriteria":707,"healthyVolunteers":437,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":708,"targetDuration":4,"studyType":23,"phases":710,"briefSummary":711,"conditions":712,"keywords":714,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":720,"lastUpdatePostDateStruct":721,"startDateStruct":723,"completionDateStruct":725,"leadSponsor":727,"locationsCount":4},"100612512","a-qualitative-study-on-gratitude-and-recognition-toward-living-kidney-donors-100612512","NCT07254546","A Qualitative Study on Gratitude and Recognition Toward Living Kidney Donors","GRAtitude et Considération Envers Les Donneurs Vivants du Rein","GRACE","Inclusion Criteria:\n\n* Individuals who have donated a kidney at Hôpital Saint-Louis between January 1, 2020, and December 31, 2025, or are currently engaged in a living kidney donation process with nephrectomy scheduled before June 30, 2026.\n* Age ≥ 18 years.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Refusal or opposition to participate in the study.\n* Individuals under legal protection (guardianship, curatorship, or legal safeguard).\n* Individuals deprived of liberty by judicial or administrative decision.\n* Individuals under 18 years of age.\n* Kidney donation performed in a hospital other than Hôpital Saint-Louis.",{"count":709,"type":22},15,[90],"Kidney transplantation is widely recognized as the best treatment for patients with end-stage renal disease. However, its development is limited by the persistent shortage of available organs. Living donor kidney transplantation offers the best functional and survival outcomes, yet the number of procedures remains insufficient.\n\nLiving kidney donation relies on a voluntary and altruistic act by a healthy individual who accepts surgery without direct medical benefit. This act of generosity raises important questions regarding how society acknowledges and values such commitment. The lack of formal recognition may contribute to the psychological burden experienced by some donors and may not adequately reflect the gratitude of the medical community and society toward them.\n\nThis study aims to explore the perceptions of living kidney donors regarding the potential implementation of a symbolic form of recognition (for instance, a commemorative medal) offered after donation. The hypothesis is that such recognition could improve donors' post-donation experience and strengthen the societal value associated with living organ donation, while fully respecting ethical principles prohibiting any financial reward.\n\nThis is a qualitative, monocentric study based on semi-structured interviews with individuals who have donated a kidney. The interviews will focus on donors' motivations, their personal experience of donation, and their opinions about different possible forms of post-donation recognition. Interviews will be recorded, transcribed verbatim, and analyzed using inductive thematic analysis to identify recurring themes and perspectives.\n\nThe main endpoint is the identification of thematic categories related to donors' perception of post-donation recognition and its potential impact on their experience. Secondary objectives include exploring donors' expectations regarding societal gratitude, their views on the symbolic value of such recognition, and the potential influence on future donor engagement.\n\nThe findings of this study are expected to contribute to the ethical reflection surrounding the acknowledgment of living donors, support initiatives promoting non-financial recognition, and help develop respectful and meaningful ways of expressing societal gratitude toward those who make the gift of life possible.",[29,713],"Nephrectomy,Kidney Donation",[715,716,717,718,719],"Incentive","Living donor","Living donor nephrectomy","Living kidney donation","Gratitude","2025-11-25",{"date":722,"type":39},"2025-11-28",{"date":724,"type":22},"2026-01-01",{"date":726,"type":22},"2026-08-01",{"name":728,"class":77},"Assistance Publique - Hôpitaux de Paris",{"id":730,"slug":731,"hasResults":12,"nctId":732,"briefTitle":733,"officialTitle":733,"acronym":734,"eligibilityCriteria":735,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":736,"targetDuration":4,"studyType":23,"phases":737,"briefSummary":738,"conditions":739,"keywords":740,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":746,"lastUpdatePostDateStruct":747,"startDateStruct":749,"completionDateStruct":751,"leadSponsor":753,"locationsCount":273},"100591098","cmv-associated-immunomodulation-in-renal-transplant-patients-100591098","NCT06976008","CMV-associated Immunomodulation in Renal Transplant Patients","IMMCMV","Inclusion Criteria:\n\n1. st cohort :\n\n   * Age \\> 18 years\n   * patients with end-stage renal failure programmed for kidney transplantation with a live donor\n2. nd cohort :\n\n   * Age \\> 18 years\n   * kidney transplant recipient with CMV viremia\n\nExclusion Criteria:\n\n\\- Patients under guardianship, curatorship, legal protection.\n\nFor patients with end-stage renal failure scheduled to receive a kidney transplant from a living donor :\n\n* Patients with an active viral (other than CMV), bacterial or fungal infection at the time of inclusion\n* patients receiving a desensitization protocol (ABO or anti-HLA)",{"count":313,"type":22},[90],"Cytomegalovirus (CMV) infection has been associated with an increased risk of bacterial, fungal and viral infections in solid organ transplant recipients. The purpose of this study to evaluate if the occurrence of CMV viremia modify the ability to develop optimal immune responses against other pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.",[29],[741,742,743,744,745],"Kidney transplant","Solid organ transplantation","Cytomegalovirus infection","Immunomodulatory effect of cytomegalovirus infection","Heterologous infection","2025-09-05",{"date":748,"type":39},"2025-09-12",{"date":750,"type":22},"2025-10-01",{"date":752,"type":22},"2029-10-01",{"name":728,"class":77}]