[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allograft\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allograft":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100568090","phase-4-study-to-compare-the-outcome-of-receiving-continued-immunosuppression-versus-stopping-immunosuppression-at-6-months-to-safely-prevent-human-leukocyte-antigen-hla-sensitization-in-patients-with-late-renal-graft-failure-100568090",false,"NCT06676696","Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure","A Multi-centre, Open, Prospective, Randomized, Parallel-group, 24-month Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure","Inclusion Criteria:\n\n* Patient must be able to understand and provide written informed consent\n* Patients older than 18 years who had received at least one previous renal transplant\n* Patients with a retained kidney graft failed for any reason which survived at least 3 months\n* Patients on dialysis, either hemodialysis or peritoneal dialysis. Patients can be on dialysis for a maximum of 6 months at the time of randomization, as long as the patients have taken an uninterrupted immunosuppressive regimen of calcineurin inhibitors (tacrolimus or cyclosporine) and steroids since dialysis was restarted\n* Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria\n* Patients taking immunosuppressants tacrolimus or cyclosporine\n* cPRA at the time of randomization ≤ 90%\n\nExclusion Criteria:\n\n* Patients who have received another solid organ transplantation (liver, lung, heart or pancreas)\n* Patients waiting for a living related \u002F unrelated kidney transplant\n* Graft survival of the failed graft lower than 3 months\n* Patients in dialysis more than 6 months at the time of randomization\n* Patients not accomplishing criteria to relist in the transplantation list according to the treating physician criteria\n* Pregnant women\n* Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Patients should use one of the acceptable birth control measures recommended in the document \"Recommendations related to contraception and pregnancy testing in clinical trials\" published by the Clinical Trials Facilitation and Coordination Group (CTFG) (version 1.1, published 21\u002F09\u002F2020). Recommended birth control measures include oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, or sexual abstinence. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry.","ALL","18 Years",{"count":19,"type":20},202,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (\\> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.\n\nThe main question this study aims to answer is:\n\nDoes maintaining long-term immunosuppression in patients with a late renal graft failure (\\> 3 months) safely reduce the risk of HLA sensitization?\n\nTo answer this question, patients will be assigned to a control arm or investigational arm:\n\n* Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.\n* Patients assigned to the investigatonal arm will continue immunosuppressant treatment at low doses for 2 years.\n\nPatients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.",[26,27,28,29,30],"Renal Failure , Chronic","Graft Failure","Graft Rejection","Allograft","Renal Failure Chronic Requiring Dialysis",[32,33,34,35,36],"Renal failure","immunosuppressor","HLA sensitization","Graft failure","Calcineurin inhibitors","RECRUITING","2024-11-05",{"date":40,"type":41},"2024-11-06","ACTUAL",{"date":43,"type":41},"2024-01-22",{"date":45,"type":20},"2028-01-31",{"name":47,"class":48},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100474536","heartcare-immuno-optimization-in-cardiac-allografts-mosaic-100474536","NCT05459181","HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)","Molecular Outcome Surveillance Using AlloSure and AlloMap Guided Immunomodulation in Cardiac Transplant","MOSAIC","Inclusion Criteria:\n\n1. Heart transplant recipients \\\u003C2 weeks post-transplant\n2. Patients aged 18 years or older\n3. Planned post-transplant maintenance immunosuppression regimen consisting of prednisolone, tacrolimus and mycophenolate\n4. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter\n5. Participant is willing and able to give informed consent for participation in the trial\n6. In the Investigator's opinion, is able and willing to comply with all trial requirements\n\nExclusion Criteria:\n\nThe participant may not enter the trial if ANY of the following apply:\n\n1. Multi-visceral transplant recipients\n2. Female participant who is pregnant, lactating or planning pregnancy during the trial\n3. Heart transplant recipients undergoing desensitization protocols prior to transplant based off high immunological risk profiles (determined by treating clinician)\n4. Chronic oral steroid use for any reason that cannot be tapered off and discontinued\n5. Planned post-transplant immunosuppression regimen utilizing cyclosporine, azathioprine, mTOR inhibitors, and\u002For co-stimulatory blockers\n6. Contraindication to having AlloSure or AlloMap testing\n7. Participant with life expectancy of less than 6 months or is inappropriate for immuno-optimization (including those patients at increased risk of primary disease recurrence w\u002F reduction in post-transplant immunosuppression)\n8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. This includes clinical events that would significantly impact post-transplant immunosuppression such as major infectious complications or significant rejection episodes within the first month post-transplant.\n9. Participants who are currently or have previously participated in another research trial involving an investigational immunological drug in the past 12 weeks\n10. Any condition that would preclude protocol biopsies\n\nRandomization Criteria (assessed at Week 4)\n\nThe participant may not proceed with randomization if ANY of the following apply at Week 4 post-transplant:\n\n1. Maintenance immunosuppression that includes cyclosporine, azathioprine, mTOR inhibitors, and\u002For co-stimulatory blockers\n2. Any episodes of biopsy-proven acute rejection (ACR ≥2R or AMR\\*)\n3. Abnormal molecular profile defined as AlloSure \\>0.2%\n4. Allograft dysfunction defined as LVEF \\\u003C45%\n5. eGFR \\\u003C30mL\u002Fmin\n6. Presence of DSA (persistence of any pre-transplant DSA or dnDSA) \\*AMR 1 (H+) with DSA\u002Fgraft dysfunction or AMR \\> 2",{"count":59,"type":20},930,[61],"NA","This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation. The aim of the study is to determine whether patients at low risk of rejection can safely reduce the doses of their post-transplant immunosuppression medications using a combination of tests that include donor-specific antibodies (DSA), histology (looking at tissue from the donor heart), donor-derived cell-free DNA (AlloSure), and gene expression profiling (AlloMap). Eligible participants will be randomized in a 1:1 ratio into the HeartCare immune-optimization (intervention) arm or the corresponding observational (control) arm. AlloSure and AlloMap are the components of the HeartCare panel developed by CareDx.",[64,65,29],"Heart Transplant","Immunosuppression",[67,68,36,69,70,71,72,73,74,75],"HeartCare","Allograft loss and survival","Chronic immunosuppression","Steroid avoidance","Donor-specific antibodies","Donor-derived cell-free DNA","AlloSure","AlloMap","Gene expression profiling","NOT_YET_RECRUITING","2024-10-21",{"date":79,"type":41},"2024-10-23",{"date":81,"type":20},"2025-12",{"date":83,"type":20},"2026-09",{"name":85,"class":86},"CareDx","INDUSTRY",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":49},"100561502","clinical-efficacy-and-long-term-outcomes-of-allograft-versus-stented-biological-prosthesis-for-primary-tricuspid-valve-disease-allotri-100561502","NCT06591000","Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)","Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease","Inclusion Criteria:\n\n* Patients with primary tricuspid valve disease and\u002For tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.\n\n  * Intraoperative findings suggested for tricuspid valve replacement rather than repair.\n\nExclusion Criteria:\n\n* Pregnancy\n\n  * Confirmed active drug addiction\n  * Progressive HIV-infection\n  * HIV-infected patients with CD4-cells count less than 250\n  * Patients with secondary tricuspid valve pathology (left-sided valve disease)\n  * LV Ejection fraction less than 40%","70 Years",{"count":96,"type":20},56,"OBSERVATIONAL","The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases.",[29,100,101],"Bioprosthesis","Tricuspid Valve Disease","2024-09-07",{"date":104,"type":41},"2024-09-19",{"date":106,"type":41},"2016-01-14",{"date":108,"type":20},"2025-06-14",{"name":110,"class":111},"Chelyabinsk Regional Clinical Hospital","OTHER_GOV"]