[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-transplant-rejection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-transplant-rejection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,43,73,94,119,149,177,206,225,242,267,288,319,342,380,405,428,449,472,507,528],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100624656","phase-2-a-study-to-investigate-the-efficacy-and-safety-of-frexalimab-versus-tacrolimus-in-adults-undergoing-kidney-transplantation-100624656",false,"NCT07412470","A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation","A Seamless Phase 2\u002F3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients","FREXERA","Inclusion Criteria:\n\n* Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.\n* Participants with low to moderate immunological risk.\n\nExclusion Criteria:\n\n* Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death.\n* Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening.\n* Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation.\n* Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy\n* Evidence of active or latent TB, HIV, HBV or HCV infection.\n* Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.\n* Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years","70 Years",{"count":21,"type":22},526,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligible if they meet all inclusion and no exclusion criteria. Study details include:\n\n* The study and treatment duration will be up to approximately 5 years.\n* The number of visits will be approximately 38.",[29],"Kidney Transplant Rejection","RECRUITING","2026-06-18",{"date":33,"type":34},"2026-06-23","ACTUAL",{"date":36,"type":34},"2026-03-13",{"date":38,"type":22},"2033-08-15",{"name":40,"class":41},"Sanofi","INDUSTRY",26,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100624918","evaluating-urinary-cxcl10-for-enhanced-detection-of-acute-rejection-in-kidney-transplant-patients-with-low-dd-cfdna-100624918","NCT07415876","Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA","Evaluating Urinary CXCL10 for Enhanced Detection of Acute Rejection in Kidney Transplant Patients With Low DD-CFDNA: Diagnostic Performance and Transport Stability Across Shipping Conditions (CLEAR-CXCL10)","Prospective Inclusion Criteria:\n\n* Age ≥18 years\n* Undergoing a clinically indicated biopsy\n* Able to provide informed consent\n* Willing to provide a urine sample and allow access to relevant clinical\n\nRetrospective Inclusion Criteria:\n\n* Age ≥18 years\n* Biopsy-confirmed rejection (positive histology)\n* Donor-derived cell-free DNA\\\u003C1% result at time of biopsy\n* Availability of stored urine sample collected at time of biopsy\n\nExclusion Criteria (applies to both arms):\n\n* Individuals under 18 years of age\n* Individuals unable to provide informed consent (for prospective enrollment)\n* Pregnant women\n* Prisoners\n* Adults unable to consent",{"count":51,"type":22},50,"OBSERVATIONAL","Kidney transplant rejection remains a significant challenge to long-term graft survival. While histological biopsy continues to be the gold standard for diagnosing rejection, noninvasive biomarkers such as donor-derived cell-free DNA (dd-cfDNA) have gained traction for their ability to detect allograft injury. However, dd-cfDNA may lack sensitivity in certain clinical scenarios particularly in cases of localized immune activation leading to false negatives despite biopsy-confirmed rejection.",[29],[56,57,58,59,60,61],"CXCL10","CXCR3+T cells","ccfDNA","dd-cfDNA","ABMR","TCMR","2026-06-09",{"date":64,"type":34},"2026-06-10",{"date":66,"type":34},"2026-06-04",{"date":68,"type":22},"2027-01",{"name":70,"class":71},"Virginia Commonwealth University","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":72},"100538458","phase-2-screening-for-subclinical-antibody-mediated-rejection-and-efficacy-of-belatacept-in-the-context-of-de-novo-donor-specific-antibody-after-kidney-transplantation-bela-m-r-100538458","NCT06291103","Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)","BELA-M-R","Inclusion Criteria:\n\n1. Screening inclusion criteria:\n\n   * Kidney transplant recipient\n   * Adult\n   * De novo DSA (MFI \\> 1000 using the Luminex single antigen beads assay or positive with the manufacturer criteria according to the Luminex assay) absent on the day of kidney transplantation and in the sera prior to kidney transplantation\n   * No clinical graft dysfunction at time of DSA detection (\\\u003C 20 % variation of eGFR compared to last 3 months before detection and \\\u003C 0,5 g\u002Fg proteinuria\u002Fcreatinuria ratio)\n   * Affiliation with, or beneficiary of a Social security (national health insurance) category\n   * Person having read and understood the information letter and signed the consent form\n   * Women of childbearing potential with effective contraception\u002Fvery-effective contraception (Cf. CTFG) (oestro-progestatives or intra-uterine device or tubal ligation) and a negative blood pregnancy test.\n   * Women surgically sterile (absence of ovaries and\u002For uterus)\n   * Postmenopausal women: confirmation diagnostic (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit)\n2. Randomization inclusion criteria:\n\n   * Patients with active sABMR, according Banff 2019 classification, with very slight transplant glomerulogathy (cg = 0 or 1).\n\nExclusion Criteria:\n\n1. Screening exclusion criteria:\n\n   * Minor\n   * Specific treatment for DSA occurrence before kidney graft biopsy: IVIG or rituximab or plasmapheresis or immunoabsorption\n   * ABO incompatible kidney transplantation\n   * Combined transplantation\n   * Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.\n   * Hypersensitivity to the active substance or to any of the excipients - Pregnant or parturient or breastfeeding woman or absence of contraception\n   * Person deprived of liberty by an administrative or judiciary decision or person placed under judicial protection, under guardianship or supervision\n   * Person consenting to the research participating to another trial\n   * Medical history or psychological or sensorial abnormality prone to inhibit the subject to understand the conditions required for his\u002Fher participation to the protocol or unable him\u002Fher to give an informed consent\n   * No signed ICF\n2. Randomization exclusion criteria:\n\n   * No sABMR or chronic active sABMR (cg \\> 1) on initial biopsy\n   * History of severe opportunistic infection before randomization\n   * Acute or chronic infection with HBV, HCV or HIV\n   * EBV negative serology\n   * History of post-transplant lymphoproliferative disorder.",{"count":81,"type":22},290,[25,26],"Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs) (phenotype 2). Preexisting DSA-associated ABMR have superior graft survival compared with dnDSA-associated ABMR, which could partly be explained by the fact that patients with de novo DSA-associated ABMR have biopsy later, when graft dysfunction and\u002For proteinuria are already present. ABMR is a progressive process with an early stage called subclinical ABMR (sABMR), in which histological lesions are present in the kidney graft without clinical graft dysfunction. These early lesions are now well recognized as risk factors for transplant glomerulopathy and poor graft survival in phenotype 1 ABMR (ref 5). The impact of sABMR associated with dnDSA at any time post-transplant has been less studied and reported. Recently, a retrospective multicenter study was published, within the Spiesser Group that included 123 patients without graft dysfunction who underwent graft biopsy because of the presence of dnDSA (One Lambda, MFI \\> 1000). Performing a kidney graft biopsy after dnDSA indentification without renal dysfunction leads to the diagnosis of active sABMR in 35 % of cases. Nevertheless, no effect of standard of care treatment in active sABMR was observed. Very recently, an expert consensus for the recommended treatment for ABMR after KT was published. It was conclude that the clear lack of evidence but a standard of care for ABMR was nevertheless defined. Therefore, the current proposal is to evaluate a new strategy for active sABMR, testing a conversion from calcineurin inhibitor (CNI) to belatacept associated with the recently recommended standard of care (SOC) compared to continuing CNI. Belatacept might help to manage nonadherence, decrease the toxicity of CNI on an endothelium already affected by microvascular inflammation, and reduce DSA titers.\n\nThe monitoring of dnDSA after KT and an indication graft biopsy in case of appearance, even in the absence of graft dysfunction, is not part of a routine clinical practice in all KT centers. This strategy could be a valuable option, in order to begin treatment of ABMR before graft dysfunction occurs, and therefore to improve prognosis associated with phenotype 2 ABMR. Parajuli et al.4 suggested that early diagnosis and treatment of sABMR with SOC, using DSA monitoring may improve outcomes after KT, but this is a retrospective and no-randomized study. This study will be the first prospective randomized study in the context of de novo DSA. The objective is to evaluate a new combination of treatment for ABMR in the context of dnDSA with subclinical lesions and in the same time may help to determine the real incidence of sABMR in KT recipients with subclinical dnDSA. The use of belatacept in the context of sABMR to improve the non-adherence and to decrease the endothelial toxicity had never been evaluated in a prospective way.",[29],"NOT_YET_RECRUITING","2026-06-05",{"date":62,"type":34},{"date":89,"type":22},"2026-07-01",{"date":91,"type":22},"2032-08-01",{"name":93,"class":71},"University Hospital, Rouen",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100380908","trifecta-kidney-cfdna-mmdx-study-100380908","NCT04239703","Trifecta-Kidney cfDNA-MMDx Study","Trifecta-Kidney cfDNA-MMDx Study: Comparing the DD-cfDNA Test to MMDx Microarray Test, Central HLA Antibody Test, and Histology.","Inclusion Criteria:\n\n* All kidney transplant recipients undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enroll in the study.\n\nExclusion Criteria:\n\n* Patients will be excluded from the study if they decline participation or are unable to give informed consent or multiple organ recipients.",{"count":102,"type":22},300,"Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood, and the Molecular Microscope® (MMDx) Diagnostic System results in indication biopsies.",[29],[106,107,108],"donor derived cell-free DNA","blood","kidney biopsy","2026-06-01",{"date":111,"type":34},"2026-06-02",{"date":113,"type":34},"2019-12-01",{"date":115,"type":22},"2029-12",{"name":117,"class":71},"University of Alberta",31,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":148},"100586716","phase-1-treatment-of-antibody-mediated-rejection-abmr-with-carbel-100586716","NCT06918990","Treatment of Antibody-Mediated Rejection (ABMR) With CarBel","Targeting the B Cell Response to Treat Antibody-Mediated Rejection With Carfilzomib and Belatacept (CarBel)","CarBel","Inclusion Criteria:\n\n1. Able to understand and agree to participate in the study.\n2. Have received a kidney transplant from a living or deceased donor (including re-transplants).\n3. Men and women must agree to use birth control during the study and for 3 months after the last dose of study drugs, or be surgically sterile or post-menopausal.\n4. Heart function must be good enough (LVEF of at least 40%) without severe heart issues or high blood pressure in the lungs.\n5. Must have been previously exposed to the Epstein-Barr Virus (EBV).\n6. Diagnosed with specific types of kidney transplant rejection based on criteria, with certain conditions on timing and treatment history.\n7. Kidney function must be at a certain level (eGFR of at least 30 ml\u002Fmin\u002F1.73 m²).\n8. Specific scores related to kidney biopsy results must be within certain limits.\n9. Patient is ≥6-months post-transplant or is \\\u003C6 months post-transplant but has documentation that they have been offered and\u002For received the local standard of care treatment prior to enrollment.\n10. Must have a measurable level of specific antibodies against the donor kidney (HLA DSA) with a certain intensity.\n11. Up-to-date vaccinations according to guidelines for transplant patients.\n12. Must have a negative tuberculosis (TB) test and chest x-ray before enrollment, no symptoms or known contact with TB, and not have recently traveled to or lived in areas with high TB rates. If previously infected with TB, must have completed treatment and have a recent negative chest x-ray.\n13. If previously infected with COVID-19, must be fully recovered for at least 21 days before joining the study. No COVID-19 test required for those without symptoms.\n\nExclusion Criteria:\n\n1. Unable or unwilling to give consent or follow study rules.\n2. Kidney transplant with incompatible blood types.\n3. Very high levels of protein in urine, indicating severe kidney issues.\n4. Previously had a non-kidney organ or bone marrow transplant.\n5. Any other medical issues that might increase risk, make following the study rules hard, or affect study results, as judged by the study doctor.\n6. Heart attack within the last year, uncontrolled chest pain, or signs of a recent heart problem on an ECG.\n7. Severe heart failure (Class 3 or higher).\n8. Irregular heartbeats that can't be controlled with medication.\n9. Participants who are actively receiving any of the therapies listed below, or who have previously received these therapies without meeting the required washout period prior to the qualifying biopsy and donor-specific antibody (DSA) assessment:\n\n   * ≥4 weeks since last dose: IVIG (intravenous immunoglobulin), therapeutic plasma exchange (TPE)\n   * ≥6 weeks since last dose: Proteasome inhibitors\n   * ≥3 months since last dose: Eculizumab; lymphocyte-depleting agents (e.g., rabbit anti-thymocyte globulin, alemtuzumab); anti-CD20 agents\n   * ≥6 months since last dose: Anti-CD38 agents; anti-IL-6 agents\n10. Used any experimental drug not specified within the last 4 weeks or longer if the drug stays in the body longer.\n11. Serious medical or mental health issues that could interfere with the study.\n12. Cancer diagnosis or treatment within the past 2 years, except for certain skin cancers or cancers with a high cure rate.\n13. Known allergy to Captisol® (used in the study drug).\n14. Very low blood counts (hemoglobin, neutrophils, or platelets).\n15. Positive for HIV, Hepatitis B, or Hepatitis C, unless Hepatitis C was successfully treated.\n16. Severe infections needing treatment in the last 4 weeks.\n17. Specific kidney infection (BK nephropathy) or high levels of BK virus.\n18. Certain kidney biopsy results indicating other types of rejection or kidney diseases.\n19. Treated for a specific viral infection (CMV) in the last 90 days or resistant to certain CMV treatments.\n20. Received a live vaccine in the last 4 weeks.\n21. Severe liver disease or abnormal liver tests.\n22. Pregnant or breastfeeding women. Women who can become pregnant must have a negative pregnancy test or proof they are not pregnant.\n23. Any other significant medical condition that could interfere with the study according to the doctor.\n24. Received certain antibody treatments in the last 3 months.\n25. Kidney rejection within 6 months post-transplant without standard care.\n26. Confirmed severe protein levels in urine.\n27. Underwent certain treatments from the time of entry DSA result and biopsy screening.\n28. History of multiple unprovoked blood clots.\n29. Diagnosed with Atypical Hemolytic Uremic Syndrome (aHUS).","75 Years",{"count":129,"type":22},25,[131],"PHASE1","The purpose of this study is to evaluate the safety and efficacy of carfilzomib and belatacept, administered with steroids and maintenance immunosuppression, in kidney transplant recipients with donor-specific antibody (DSA)-associated graft injury. Participants will be followed for 52 weeks after starting investigational therapy, including protocol biopsies at 3 months and 12 months after start of investigational therapy. The study will also assess changes in immune cell responses, blood and urine biomarkers, and biopsy-based pathomic features associated with antibody-mediated graft injury.",[29],[135,136,137],"Carfilzomib","Kidney transplant","Belatacept","2026-05-22",{"date":140,"type":34},"2026-05-26",{"date":142,"type":22},"2026-05-29",{"date":144,"type":22},"2027-06-30",{"name":146,"class":147},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",10,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":72},"100634451","phase-2-belimumab-to-mobilise-memory-b-cells-from-secondary-lymhoid-organs-to-improve-memory-b-cell-hla-specificity-profiling-to-support-delisting-for-transplant-access-in-highly-sensitized-100634451","NCT07539857","Belimumab to Mobilise Memory B-cells From Secondary Lymhoid Organs to Improve Memory B-cell HLA-specificity Profiling to Support Delisting for Transplant Access in Highly-sensitized","BE-MOBILYZED","To be eligible for participation in this study, a subject must meet all of the following criteria:\n\nAdults aged ≥18 and ≤75 years Candidate for kidney transplantation\n\nHighly sensitized, as determined by either:\n\n* 2% probability of being matched with a donor organ within the Eurotransplant Kidney Allocation System (ETKAS), or\n* 0.5% probability of being matched with a donor organ within the Eurotransplant Acceptable Mismatch (AM) program, if eligible for inclusion in this program Provision of written informed consent for participation in this study Willingness and ability to comply with the study protocol\n\nFemale subjects are eligible if they meet one of the following criteria:\n\nNot pregnant or breastfeeding, as confirmed by a negative pregnancy test at screening Of non-childbearing potential (i.e., status post hysterectomy, postmenopausal, bilateral oophorectomy, documented bilateral tubal ligation, or other permanent sterilization procedure) Of childbearing potential and willing to use effective contraception and agree not to become pregnant during the study\n\nA potential subject who meets any of the following criteria will be excluded from participation:\n\nActive pregnancy, as confirmed by a positive urine β-hCG test or a positive serum β-hCG test, adjusted for end-stage renal disease (ESRD) Significant hypogammaglobulinemia (IgG \\\u003C4.0 g\u002FL) or IgA deficiency (IgA \\\u003C0.1 g\u002FL) Receipt of any vaccination within 3 months prior to screening Enrollment in another clinical trial investigating an investigational drug or device at the time of belimumab treatment and delisting; participation in a desensitization trial after assessment of the primary outcome is permitted\n\nPrevious administration of any of the following agents within 365 days prior to screening:\n\nBAFF inhibitors (e.g., belimumab, tabalumab) Monoclonal antibodies targeting CD20 (e.g., rituximab) Monoclonal antibodies targeting CD52 (e.g., alemtuzumab) Lymphocyte-depleting agents (e.g., rATG, ATGAM) IL-6 inhibitors or IL-6\u002FIL-6R modulators (e.g., tocilizumab, clazakizumab) Proteasome inhibitors (e.g., bortezomib) Previous administration of high-dose corticosteroids (\\>50 mg prednisolone or equivalent per day) within 90 days prior to screening\n\nActive infection at screening, defined as any of the following:\n\nHospitalization for treatment within 30 days prior to screening Current use of parenteral (intravenous or intramuscular) antimicrobial therapy (including antibacterial, antiviral, antifungal, or antiparasitic agents) Current serologic evidence of viral hepatitis, defined as positivity for HBsAg or HBcAb, or a positive hepatitis C antibody test without antiviral treatment Uncontrolled HIV infection, defined as CD4 count \\\u003C250 cells\u002Fmm³ and\u002For detectable viremia History of a primary immunodeficiency, including complement deficiencies Neutrophil count \\\u003C1.5 × 10⁹\u002FL Current indication for blood product transfusion at screening, or a high likelihood of requiring transfusion during the treatment phase, in the opinion of the investigator Significant history of infections that, in the opinion of the investigator, would make participation unsuitable History of anaphylactic or severe allergic reaction to parenteral administration of human or murine proteins or monoclonal antibodies Active malignancy or a history of malignancy within the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix with no evidence of metastatic disease for at least 3 years Evidence of psychiatric illness that, in the opinion of the investigator, would make participation unsuitable Any other abnormal laboratory value or intercurrent medical condition that, in the opinion of the investigator, would make participation unsuitable Known mental incapacity or language barriers precluding adequate understanding of the informed consent process and study procedures",true,{"count":129,"type":22},[25],"The goal of this clinical trial is to determine whether belimumab can improve detection of circulating HLA-specific memory B cells to support safer and more effective donor organ allocation in highly sensitized kidney transplant candidates.\n\nThe main questions it aims to answer are:\n\nDoes treatment with belimumab change the antigen specificity profile of circulating HLA-specific memory B cells compared to pre-treatment measurements?\n\nDoes a delisting strategy that incorporates mobilized memory B cells improve the probability of donor organ allocation and reduce time to transplantation?\n\nParticipants will:\n\nReceive a short course of belimumab treatment\n\nProvide blood samples before and during treatment to assess memory B-cell profiles\n\nUndergo evaluation for potential adjustment of unacceptable HLA specificities (delisting) based on test results\n\nBe followed for donor organ allocation and transplantation outcomes",[29],[162,163,164,165,166,167],"HLA","Memory B cell","Belimumab","Highly sensitized","Delisting","Kidney transplantation","2026-04-13",{"date":170,"type":34},"2026-04-20",{"date":172,"type":22},"2026-04-01",{"date":174,"type":22},"2030-01-01",{"name":176,"class":71},"Leiden University Medical Center",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":72},"100472506","aiim-trial-personalized-medicine-approach-to-kidney-allograft-function-100472506","NCT05432765","AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function","AIIM Trial: Protecting Kidney Function After Transplantation Using Augmented Intelligence Based Immunosuppression Dosing","AIIM","Inclusion Criteria:\n\n* Adult (18 years of age or older) patients with end-stage renal disease (ESRD)\n* Recipient of a first or subsequent deceased donor kidney transplant\n* Clinical indication to receive tacrolimus as the primary immunosuppression\n* Willing and able to provide written informed consent to participate\n\nExclusion Criteria:\n\n* Recipients of transplanted organs other than kidney\n* Recipients of a transplant from a monozygotic (identical) sibling\n* Human Leukocyte Antigen (HLA)-identical donor (zero out of six antigen mismatch donor)\n* Recipient of third or more transplant\n* Current or historical panel reactive antibodies of more than 50%\n* Blood Type (ABO) incompatibility or known moderate or strong donor specific antibodies\n* De novo or recurrent glomerulonephritis on 3-month biopsy\n* Lupus nephritis on 3-month biopsy\n* Focal segmental glomerulosclerosis on 3-month biopsy\n* BK polyomavirus nephropathy in current or prior transplant\n* Recipient of a bone marrow transplant\n* Recipient who is pregnant\n* Enrollment in a competing trial that would interfere with selection or alteration of immunosuppression\n* Inability to follow up with transplant center for up to 15 months after transplantation\n* Anticipated major surgery during the time of planned study\n* Major medical illness with life expectancy less than 15 months\n* Suspicion of noncompliance\n* Anticipated relocation to a location that would not allow follow up at local center in the next 18 months\n* Inability to tolerate normal range levels of tacrolimus","99 Years",{"count":187,"type":22},34,[189],"NA","The objective of the proposed study it to perform a pilot clinical trial both to establish feasibility of applying a computational, augmented intelligence based approach, Phenotypic Precision Medicine (PPM), to optimizing combination drug therapy and to gather preliminary data to support a larger fully powered multi-center clinical trial. The key rationale for this clinical selection is that we have the technical, biological, and medical expertise in this disease, a wealth of experience in the use of PPM in both in vitro and the clinical setting, and a robust and integrated transplant program with a well-functioning clinical trial infrastructure.",[29],[193,194,195,196],"Kidney","Transplant","dd-cf DNA","Personalized Medicine","2026-02-09",{"date":199,"type":34},"2026-02-10",{"date":201,"type":22},"2026-12",{"date":203,"type":22},"2031-01-01",{"name":205,"class":71},"University of Florida",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100593380","using-mscs-for-chronic-active-antibody-mediated-rejection-100593380","NCT07005687","Using MSCs for Chronic Active Antibody Mediated Rejection","Inclusion Criteria:\n\n* chronic active antibody mediated rejection in kidney transplanted recipients\n\nExclusion Criteria:\n\n\\-",{"count":148,"type":22},[189],"Mesenchymal stem cell (MSCs) therapy has already been studied in kidney transplant recipients (KTRs), and the available data showed that it is safe and well tolerated. The aim of this study was to evaluate the safety and efficacy of autologous MSCs in combination with standard therapy in KTRs with biopsy-proven chronic active antibody-mediated rejection (AMR). Patients with biopsy-proven chronic active AMR received treatment with autologous bone marrow-derived MSCs (3 × 106 cells\u002Fkg iv) after completion of standard therapy and were followed for up to 12 months. The primary endpoints were safety by assessment of adverse events. Secondary endpoints included assessment of kidney graft function, immunological and histological changes related to AMR activity and chronicity assessed by conventional microscopy and molecular transcripts. A total of 3 patients were enrolled in the study before it was terminated prematurely because of adverse events. We found that AMR did not improve in any of the patients after treatment with MSCs. In addition, serious adverse events were observed in one case when autologous MSCs therapy was administered in the late phase after kidney transplantation, which requires further elucidation.",[29],"2026-02-08",{"date":218,"type":34},"2026-02-11",{"date":220,"type":22},"2027-12-01",{"date":222,"type":22},"2029-07-01",{"name":224,"class":71},"Shahid Beheshti University of Medical Sciences",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":72},"100593445","treatment-of-chronic-active-antibody-mediated-rejection-with-tocilizumab-100593445","NCT07006532","Treatment of Chronic Active Antibody Mediated Rejection With Tocilizumab","Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients With Tocilizumab ,IVIG, Plasmapheresis, Rituximab Versus IVIG, Plasmapheresis , Rituximab","Inclusion Criteria:\n\n1. Signed written informed consent\n2. eGFR\\> 25 cc\u002Fmin\n3. Chronicity index \\\u003C8\n4. IFTA\\\u003C40%\n5. EBV IgG positive\n\nExclusion Criteria:\n\n1. Active or recurrent infections\n2. History of malignancy, unless in remission for more than 2 years with no relapse\n3. abnormal liver function tests\n4. Platelet \\\u003C 100,000",{"count":51,"type":22},[189],"Chronic active antibody mediated rejection (CAMR) is a therapeutic challenge in transplant recipients that does not respond well to conventional treatments for acute antibody mediated rejection (AMR). Annually, 5000 kidney transplants are lost in the United States due to CAMR. The two-year graft survival rate in CAMR is approximately 20%, highlighting the need for a more efficient therapy for CAMR and directly targeting donor specific antibody (DSA) producing cells and reducing CAMRThere is no established treatment for this problem. While many centers intensify and optimize the dosage of immunosuppressive drugs, treatments such as plasmapheresis, IVIG, and rituximab, although effective in treating AMR, have not been successful in reducing DSA or improving kidney graft survival in CAMR patients. Despite these treatments, two-year graft survival can increase up to 55%. The use of anti-plasma cell treatments like bortezomib has also yielded inconsistent results.",[29],{"date":218,"type":34},{"date":238,"type":34},"2025-01-01",{"date":240,"type":22},"2027-05-01",{"name":224,"class":71},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":72},"100614126","platelet-aggregation-in-the-diagnosis-of-acute-graft-rejection-100614126","NCT07275541","Platelet Aggregation in the Diagnosis of Acute Graft Rejection","Inclusion Criteria:\n\n* adult patients (≥18 years)\n* primary kidney transplantation\n* living \u002F deceased donor kidney transplantation\n* ability and consent to participate\n\nExclusion Criteria:\n\n* non-adult patients\n* secondary \u002F tertiary kidney transplantation\n* antiplatelet therapy\n* patients unable to provide informed consent",{"count":249,"type":22},60,"The study titled \"Platelet Aggregation in the Diagnosis of Acute Graft Rejection\" is a pilot observational study evaluating whether alterations in platelet function can serve as non-invasive markers of acute rejection in kidney transplant recipients. Platelet aggregation is assessed using optical aggregometry, flow-cytometric P-selectin (CD62-P) expression, and soluble P-selectin levels before kidney transplantation and at the time of protocol biopsies performed at 3 and 12 months after kidney transplantation. Patients with suspected graft dysfunction undergoing indication biopsy are also included. Platelet activation markers are correlated with histopathological findings, donor-specific antibodies, metabolic parameters, and clinical outcomes. The goal is to determine whether platelet activation profiles can identify acute cellular or antibody-mediated rejection and contribute to the development of a non-invasive diagnostic tool.",[252,29],"Platelet Aggregation",[254,255,256,257],"kidney transplantation","platelet aggregation","acute rejection","non-invasive marker","2025-11-27",{"date":260,"type":34},"2025-12-10",{"date":262,"type":34},"2024-11-26",{"date":264,"type":22},"2027-11-26",{"name":266,"class":71},"University Hospital, Martin",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":148},"100597609","validation-of-donor-derived-cell-free-dna-dd-cfdna-for-kidney-transplant-monitoring-100597609","NCT07060716","Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring","GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring","Inclusion Criteria:\n\n1. Subject is 18 years of age or older\n2. At least 12 calendar days have elapsed since the subject received a kidney transplant.\n3. Subject has provided legally effective informed consent\n4. Subject agrees to comply with all study procedures\n\nExclusion Criteria:\n\n1. Kidney donor is an identical twin of the subject.\n2. The subject has another previously transplanted organ in situ.\n3. Subject has received a hematopoietic stem cell transplant.\n4. Subject has received a bone marrow graft.\n5. Subject has self-reported as pregnant.\n6. In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.\n\nSample Inclusion Criteria:\n\n1\\. A graft biopsy is obtained within ±1 week of blood draw.\n\n* If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.\n\nSample Exclusion Criteria:\n\n1. Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.\n2. Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw\n3. Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.\n4. Sample collected from a subject that provided another sample for the study within the past 7 days.",{"count":275,"type":22},125,"The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.\n\nResearchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.",[29,278],"Cell-free DNA","2025-11-18",{"date":281,"type":34},"2025-11-19",{"date":283,"type":34},"2025-09-08",{"date":285,"type":22},"2025-12",{"name":287,"class":41},"Insight Molecular Diagnostics",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":298,"conditions":299,"keywords":304,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100610726","pioneer-trial-post-transplant-application-of-trugraf-and-trac-molecular-panel-in-renal-transplant-recipients-100610726","NCT07231328","PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)","Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients","PIONEER","Inclusion Criteria:\n\n* Able to understand the key components of the study as described in the written informed consent document and willing and able to provide written informed consent.\n* At least 18 years of age at the time of screening.\n* Enrollment begins 30 days prior to transplant till day 29 post-transplantation.\n* Recipient of a kidney transplant (either primary or repeat), from either deceased or living donor.\n* Receiving any immunosuppressive regimen.\n* Able and willing to comply with all study procedures, as assessed by the Investigator.\n* Selected by the treating provider to undergo TruGraf and TRAC™ testing as part of routine post-transplant care\n\nExclusion Criteria:\n\nHistory of previous non-kidney solid organ, vascular composite allograft, pancreatic islet, stem cell, or bone marrow transplant.\n\n* History of dual or en-bloc kidney transplants.\n* Recipient or donor with positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) nucleic acid testing (NAT), hepatitis C virus (HCV) antibody, HCV NAT, human immunodeficiency virus (HIV), or HIV NAT.\n* Patients known to be pregnant or with plans to become pregnant over the 24 months after enrollment.\n* History or presence of coagulopathy, thrombophilia, unexplained bleeding or clotting disorders, or use of or documented plans for use of systemic anticoagulants at the time of screening, with the exception of uremic coagulopathy or prophylactic heparin preparations.\n* History or presence, upon clinical evaluation, of any illness or condition that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions",{"count":297,"type":22},600,"This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring.\n\nApproximately 15 U.S. sites",[300,301,302,303,29],"Immunosuppression Management","Biomarkers \u002F Blood","Subclinical Rejection","Biopsy",[305,306,307,308,309],"TRAC-ID ASSAY","Kidney Transplant rejection","TruGraf, TRAC\u002FTRAC ID biomarker panel","TruGraf","TRAC","2025-11-13",{"date":312,"type":34},"2025-11-17",{"date":314,"type":22},"2025-11-20",{"date":316,"type":22},"2029-03-31",{"name":318,"class":41},"Transplant Genomics, Inc.",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":326,"targetDuration":328,"studyType":52,"phases":4,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100540237","australian-genomics-of-chronic-allograft-dysfunction-study-100540237","NCT06314230","Australian Genomics Of Chronic Allograft Dysfunction Study","AUSCAD","Inclusion Criteria:\n\n* Living or deceased donor kidney transplant candidate.\n* Biological sex: any\n* Ages: 18-75 years.\n* Subject must be able to understand and provide informed consent.\n* Deceased donor individuals where Research Consent has been obtained from the person consenting to organ donation at the time of organ retrieval.\n* Identifiable living donors who have received informed consent and have consented to participate in the project.\n\nExclusion Criteria:\n\n* Presensitization in living donor recipients prior to transplantation, as determined by site-specific standards, OR positive cross match according to site specific technique in cadaveric donor recipients.\n* Recipients of multiple organ transplants, with the exception of kidney\u002Fpancreas transplants.\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n* High risk populations including pregnant women, children less than 18 years and prisoners will not be included in the study.\n* Non English speaking potential participants who do not understand the requirements of the study will not be included.",{"count":327,"type":22},500,"2 Years","The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles.",[29,331],"Kidney Transplant; Complications","2025-07-14",{"date":334,"type":34},"2025-07-17",{"date":336,"type":34},"2012-04-26",{"date":338,"type":22},"2040-01-01",{"name":340,"class":71},"Western Sydney Local Health District",2,{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":17,"minAge":349,"maxAge":350,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":362,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":72},"100597051","phase-1-crispr-edited-hla-donor-kidney-transplant-to-reduce-rejection-risk-100597051","NCT07053462","CRISPR-Edited HLA Donor Kidney Transplant to Reduce Rejection Risk","Phase 1\u002F2, Single-Arm, Open-Label Trial to Evaluate the Safety, Feasibility, and Immunogenicity of Ex Vivo CRISPR-Cas9 Gene-Edited Donor Kidneys (Knockout of HLA-A, HLA-B, and CIITA) in Human Renal Transplant Recipients","Inclusion Criteria:\n\n* Adult patients, age 16 to 85 years, with end-stage renal disease (ESRD) who are candidates for kidney transplantation. This includes patients on dialysis or approaching dialysis who have been evaluated and listed for transplant.\n* Eligible for transplant surgery based on medical assessment (i.e., no contraindications to major surgery and transplantation). The patient's overall health status must be sufficient to undergo the transplant procedure and the required immunosuppression.\n* Suitable donor organ available: A deceased-donor kidney that meets standard acceptable criteria for transplant (e.g., adequate organ function and anatomy) and is ABO blood type compatible with the recipient. The donor kidney must be allocated to the trial and available for ex vivo gene editing prior to transplantation.\n* Informed consent: The patient (or legally authorized representative) is able to understand the experimental nature of the study and has voluntarily signed the informed consent form. The patient must be willing to comply with all study procedures, follow-up visits, and laboratory tests.\n* Negative crossmatch (if applicable): No pre-existing anti-donor reactivity that would cause immediate graft failure. (All recipients should have a negative T and B cell crossmatch with the donor organ prior to transplant, as per standard practice, to ensure no strong baseline donor-specific antibodies, especially against any remaining donor HLA such as HLA-C.)\n* Women of childbearing potential must have a negative pregnancy test and must agree to use effective contraception during the study and for a period after (to be specified, e.g., 1 year post-transplant), given the use of immunosuppressants and the unknown effects of gene-edited organ transplantation on pregnancy. Men with partners of childbearing potential should also agree to use contraception.\n* High immunologic risk patients are eligible: Patients with high panel reactive antibody (PRA) levels or a history of sensitization (from prior transplants, blood transfusions, or pregnancies) are allowed and even anticipated in this trial, as the intervention is designed to benefit patients with broad HLA sensitization. For instance, patients with calculated PRA \\> 80% (who have difficulty finding matched donors) can be included. (Such patients must still meet the crossmatch criterion above - any existing antibodies should not target the antigens remaining on the edited graft.)\n* Geographic availability: Patients must be available for long-term follow-up in the study center in China or able to travel for scheduled follow-up visits. They should be willing to remain in proximity to the transplant center for the initial post-operative period as per standard transplant care.\n\nExclusion Criteria:\n\n* Active infection: Any ongoing severe infection that would contraindicate transplantation or be exacerbated by immunosuppression (e.g., active tuberculosis, untreated Hepatitis B or C, HIV with uncontrolled viremia, etc.). Patients with controlled HIV (on stable antiretroviral therapy with undetectable viral load) may be considered on a case-by-case basis, but active uncontrolled infection is excluded.\n* Pregnancy or breastfeeding: Pregnant women are excluded due to the need for immunosuppressive drugs and the unknown risks of the investigational intervention on a fetus. Women who are breastfeeding are also excluded due to potential drug excretion in milk and unknown risks to the infant.\n* Multi-organ transplant need: Patients requiring more than one organ transplant simultaneously (e.g., kidney + liver, or kidney + heart) are excluded, as this trial focuses on isolated kidney transplant outcomes. (A history of a prior transplant is not an automatic exclusion if the patient now only needs a kidney, but concurrent multi-organ requirements are excluded.)\n* Severe co-morbidities that would significantly increase transplant risk or confound results: for example, uncontrolled cardiovascular disease (e.g., recent myocardial infarction, severe heart failure), uncontrolled diabetes with end-organ damage beyond ESRD, severe liver dysfunction, or other life-threatening illnesses unrelated to kidney failure. Such conditions could make the surgery unsafe or the outcome hard to interpret.\n* Contraindications to immunosuppression: Patients with conditions that preclude standard immunosuppressive therapy (for instance, a history of anaphylaxis to tacrolimus or mycophenolate that cannot be managed, or chronic infection that would be fatally worsened by immunosuppression) are excluded. The trial still relies on baseline immunosuppressants, so patients must be able to tolerate them.\n* Inability to follow the protocol: Patients with significant psychiatric disorders, cognitive impairment, or social situations that would make adherence to the study protocol and follow-up unlikely. This includes inability to give informed consent or lack of support for the intensive follow-up (for example, if the patient is incarcerated or has no fixed address, etc.).\n* Prior gene therapy or organ experiment participation: Patients who have previously received any investigational gene therapy, or who have a donor-specific tolerance induction or other experimental transplant treatments ongoing, may be excluded to avoid confounding effects. (This is a precaution to attribute outcomes specifically to the CRISPR-edited organ intervention.)\n* Laboratory abnormalities: Any clinically significant abnormalities in baseline labs that would pose added risk - for instance, severe leukopenia or thrombocytopenia that could worsen with immunosuppression, or uncontrolled coagulopathy that raises surgical risk.\n* Donor-related exclusions: If the donor kidney, upon retrieval, is found unsuitable for gene editing or transplant (e.g., poor organ quality, unexpected disease in the organ, or if the CRISPR editing fails to achieve sufficient knockout of target genes), the transplant to that patient will not proceed under the study (the patient may either receive a standard transplant off-study or wait for another opportunity). In such a case, the patient might be withdrawn or deferred, but this is a procedural consideration rather than a characteristic of the patient.","16 Years","85 Years",{"count":352,"type":22},90,[131,25],"This clinical trial investigates the transplantation of donor kidneys that have been genetically modified ex vivo using CRISPR-Cas9 genome editing to reduce immunogenicity and transplant rejection. Donor kidney grafts will have key human leukocyte antigen (HLA) genes disrupted - specifically, knockout of HLA class I heavy chains HLA-A and HLA-B, along with disabling HLA class II expression by targeting the CIITA gene (a master regulator of HLA-DR\u002FDQ\u002FDP). Approximately 90 adult end-stage renal disease patients will receive a CRISPR-edited donor kidney transplant. The primary objectives are to assess the safety and feasibility of this novel intervention, while secondary objectives evaluate the reduction in immune responses (immunogenicity), graft function, and the practicality of implementing ex vivo gene-edited organ transplantation in humans. By knocking out major donor HLA molecules, the trial aims to reduce T-cell and antibody-mediated recognition of the graft, potentially lowering rejection rates and reliance on high-dose immunosuppressants. Safety, including any off-target effects or unanticipated immune reactions, will be closely monitored, and transplant outcomes will be tracked for one year post-transplant.",[356,357,358,29,359,360,361],"End-Stage Renal Disease","End Stage Renal Disease on Dialysis","End Stage Renal Disease With Renal Transplant","Kidney Tumor","Kidney Failure","Kidney Ischemia",[363,364,365,360,366,367,368,369,370],"HLA Mismatch Immunogenicity","Transplant Rejection (Immunologic)","Kidney Transplantation (Allograft)","CRISPR-Cas9","Kidney Transplant","Human Leukocyte Antigen (HLA)","Immunogenicity Reduction","Graft Rejection Prevention","2025-06-26",{"date":373,"type":34},"2025-07-08",{"date":375,"type":34},"2025-06-01",{"date":377,"type":22},"2028-12-28",{"name":379,"class":71},"AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":387,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":404},"100419027","impact-of-the-microbiota-on-the-likelihood-of-renal-graft-rejection-100419027","NCT04736381","Impact of the Microbiota on the Likelihood of Renal Graft Rejection","MERRLIN","Inclusion Criteria:\n\n* Patients called for a kidney transplant\n* Induction therapy with Simulect, maintenance therapy with Nulojix, mycophenolate acid and steroids\n* Patient having signed the informed consent\n\nExclusion Criteria:\n\n* Multiple grafts combined or sequential\n* Induction therapy with polyclonal antibodies\n* HIV or active viral infection such as hepatitis B or C\n* Active bacterial infection\n* Pregnancy or breastfeeding at time of inclusion\n* Patient unable to express their consent",{"count":388,"type":22},70,"Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.",[29],[392,137,393],"Microbiota","Second signal inhibitor","2025-04-09",{"date":396,"type":34},"2025-04-10",{"date":398,"type":34},"2021-10-07",{"date":400,"type":22},"2027-01-07",{"name":402,"class":403},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",9,{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":72},"100416388","added-value-of-18-fdg-pet-scanner-in-diagnosis-and-management-of-subclinical-rejection-in-kidney-transplant-patients-100416388","NCT04702022","Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients","Non-invasive Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients Using 18F-fluorodeoxy Glucose Positron Emission Tomography (18FDG-PET\u002FCT)","Inclusion Criteria:\n\n* Kidney recipients aged over 18 and of all sexes\n\nExclusion Criteria:\n\n* Pregnant patients\n* Polyomavirus nephropathy\n* Highly sensitised patients (historical or at 3 months Donor specific antibodies)\n* No corticosteroids withdrawal allowed (second kidney transplantation or primary disease)",{"count":51,"type":22},[189],"The renal biopsy (RB) represents the gold-standard for the diagnosis of acute renal transplant rejection (AR), and allows early verification of a so-called \"subclinical\" rejection, ie without any clinical or biological abnormality detectable in a stable kidney transplant patient. The RB also makes it possible to certify a strictly normal renal histology and thus to motivate the withdrawal of corticosteroid therapy. It is this 3-month post-transplant protocol RB protocol that has been effective since 2007 at the CHU Liège.\n\nHowever, RB is an invasive procedure, contraindicated in patients taking anticoagulants, and carrying a significant risk of complications. The potential complications associated with RB motivate the identification and validation of other diagnostic means. In the present project, the investigators propose to study the relevance of positron emission tomography (PET), coupled with conventional tomography (CT), after intravenous injection of 18-fluoro-deoxy-glucose (18FDG) in the overall protocol of the renal transplant patient at 3 months post-transplant to:\n\n(i) allow protocol renal biopsy only in patients with suspicion of an acute rejection (ii) be a decision maker for withdrawal from corticosteroids in the absence of rejection\n\nIn practice, the investigators suggest performing 18FDG PET \u002F CT imaging on the day of the surveillance biopsy, which is systematically performed in all kidney transplant patients at University Hospital of Liège 3 months after transplant. The investigators are considering 3 scenarios:\n\n* Scenario 1. The renal biopsy shows signs of humoral rejection: the patient is excluded from the study and is treated \"as usual\" on the basis of the histological results.\n* Scenario 2. The renal biopsy does not show signs of humoral rejection but the 18FDG PET \u002F CT shows a high metabolic activity of the graft (\\> 2.4): the patient is treated \"as usual\" on the basis of histological findings.\n* Scenario 3. The renal biopsy does not show signs of humoral rejection and the 18FDG PET \u002F CT shows a weak metabolic activity of the graft (\\\u003C2.4): the immunosuppressive treatment is gradually weaned off corticosteroids.\n\nThis clinical research project is interested in a major health problem in the follow-up of renal transplant patients, and could make it possible to improve the management of a subclinical rejection of the renal transplant and to increase the withdrawal of corticosteroids including side effects are well known.",[29,331],[417,418,419],"PET\u002FCT imaging","Corticoids withdrawal","SubClinical Rejection","2025-04-06",{"date":394,"type":34},{"date":423,"type":34},"2021-01-04",{"date":425,"type":22},"2027-01-01",{"name":427,"class":71},"University of Liege",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":4},"100544171","genomic-medicine-in-kidney-transplantation-study-100544171","NCT06365411","GEnomic Medicine in Kidney Transplantation Study","GEM-KiT","Inclusion Criteria: All participants included in the study must be age ≥ 18 years old at time of enrolment and\n\n1. able to provide informed consent (interpreter permitted) for enrolment\n2. consenting to longitudinal follow up (can withdraw post enrolment)\n3. consenting to provide samples for biobanking, including blood, urine, faecal and\u002For kidney biopsy tissue (collected prospectively, separate to routine care)\n\nExclusion Criteria: Patients will be excluded from the study if they are\n\n1. unable (or unwilling) to provide consent, or\n2. have life-expectancy less than 6-months, or\n3. have received a haematopoietic stem cell transplant in the past 5 years.","80 Years",{"count":437,"type":22},1000,"Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.\n\n1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation\n2. Derive polygenic risk scores on pre-transplant blood and\u002For kidney biopsy samples which predict kidney allograft dysfunction\n3. Derive polygenic risk scores on post-transplant blood and\u002For kidney biopsy samples which predict kidney allograft dysfunction",[440,29],"Transplant Complication","2025-03-24",{"date":443,"type":34},"2025-03-28",{"date":445,"type":22},"2025-06-03",{"date":447,"type":22},"2035-01-01",{"name":340,"class":71},{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":456,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"100581616","phase-1-autologous-tolerogenic-dendritic-cells-atdc-for-highly-sensitized-kidney-transplant-recipients-100581616","NCT06852625","Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients","ATDC-PICI","Inclusion Criteria:\n\n1. Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.\n2. To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.\n3. Adequate venous access and absence of contraindications for leukoapheresis.\n4. Women of childbearing age must take contraceptive measures.\n5. Must have given written informed consent\n\nExclusion Criteria:\n\n1. Subjects with active TB.\n2. Patients on the waiting list multiple organ transplants.\n3. A significantly abnormal general serum screening lab result defined as WBC\\\u003C3.0x103\u002Fml, Hgb\\\u003C8.0 g\u002FdL, platelet count \\\u003C100x103\u002Fml, SGOT\\>3x upper limit.\n4. HIV-positive subjects.\n5. Subjects who test positive for HBV infection \\[positive HBVsAg or HBVeAg\u002FDNA\\] or HCV infection \\[RNA+\\].\n6. Subjects with active CMV or EBV infection as defined by positive PCR.\n7. Subjects with a known history of previous myocardial infarction within one year of screening.\n8. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.\n9. Patients with a kidney disease with high risk of recurrence and\u002For complement-associated kidney disease (aHUS, etc).\n10. Pregnant and lactating women.","65 Years",{"count":458,"type":22},30,[131],"The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.",[29],"2025-02-24",{"date":464,"type":34},"2025-02-28",{"date":466,"type":22},"2025-05",{"date":468,"type":22},"2028-03",{"name":470,"class":71},"Fundacion Clinic per a la Recerca Biomédica",7,{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":481,"conditions":482,"keywords":488,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":72},"100518030","expanding-the-scope-of-post-transplant-hla-specific-antibody-detection-and-monitoring-in-renal-transplant-recipients-100518030","NCT06025240","Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients","HLA-AB","Inclusion Criteria:\n\n1. cf-DNA arm:\n\n   * Adult patients transplanted within 6-12 months (retrospective recruitment)\n   * Patients admitted for renal transplant or within the first 6 months following transplant (prospective recruitment)\n   * Patients must have capacity to provide informed consent\n   * Patients must have received a high-risk transplant defined as level 4 mismatch, cRF \\>20, second or subsequent transplant, ABO or HLA incompatible\n2. Older Age Immunological Events:\n\n   \\- Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant\n3. Predictive models:\n\n   * Any adult patient with capacity undergoing, or within 72 hours of, a renal transplant\n   * Unsensitized pre-transplant\n\nExclusion Criteria:\n\n1. cf-DNA arm:\n\n   * Transplanted for longer than 12 months;\n   * Low risk transplants;\n   * Patients lacking capacity;\n2. Older Age Immunological Events:\n\n   * Patients lacking capacity\n   * Patients transplanted longer than 2 weeks\n3. Predictive models:\n\n   * Sensitised patients\n   * Patients lacking capacity\n   * Patients transplanted longer than 2 weeks",{"count":480,"type":22},282,"The purpose of this study is to assess a new test to detect antibodies which may form following kidney transplant. These antibodies can be difficult to detect as they do not cause any symptoms but can lead to kidney damage. A new blood test will be performed alongside existing antibody tests to see how well the test functions in comparison and to see how well it is able to distinguish between inflammation caused by antibodies and other sorts of inflammation such as a urinary tract infection. The investigators also want to determine whether it is predictable whom will develop antibodies after a transplant and use these results to change the current way patients are monitored for antibodies after receiving a transplant. In addition to this, the investigators want to establish if patients over 60 years of age are relatively protected against immunological events such as rejection compared to patients who are under 60 years of age. The results could potentially lead to using a different immunosuppression regime based on which population age group patients belong to and lowering the risks associated with these drugs.",[367,483,29,484,331,485,486,487],"Renal Transplant Failure","Frailty","Transplant Dysfunction","Diagnosis","Renal Transplant",[489,490,491,492,493,494,495,496,497],"kidney transplant","novel biomarkers","post-transplant antibodies","HLA-specific antibodies","donor specific antibodies","transplant in older age","machine learning","predictive models","rejection","2024-08-28",{"date":500,"type":34},"2024-08-30",{"date":502,"type":34},"2023-10-13",{"date":504,"type":22},"2026-10-13",{"name":506,"class":403},"Liverpool University Hospitals NHS Foundation Trust",{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":516,"conditions":517,"keywords":518,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":526,"locationsCount":72},"100523842","reduced-dose-alemtuzumab-for-kidney-transplant-rejection-100523842","NCT06100965","Reduced-dose Alemtuzumab for Kidney Transplant Rejection","The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection","ROSETTE","Inclusion Criteria:\n\n* 18 years or older\n* Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab.\n\nExclusion Criteria:\n\n* Treatment with a different lymphocyte depleting agent (e.g. rATG) prior to treatment with alemtuzumab for the same rejection episode.\n* Recipients who have T cell counts below 200 × 106\u002FL before the start of therapy (for instance, because of lymphocyte depleting induction therapies).\n* Inability to provide written informed consent",{"count":129,"type":22},"Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.",[29],[519],"alemtuzumab","2024-02-20",{"date":522,"type":34},"2024-02-21",{"date":524,"type":34},"2023-12-01",{"date":89,"type":22},{"name":527,"class":71},"Erasmus Medical Center",{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":550},"100485404","multi-center-observation-of-sentinel-skin-graft-for-detecting-acute-rejection-after-renal-transplantation-100485404","NCT05600634","Multi Center Observation of Sentinel Skin Graft for Detecting Acute Rejection After Renal Transplantation","Multi Center Clinical Observation of Sentinel Skin Graft From the Same Donor Source for Detecting Acute Rejection After Renal Transplantation","Inclusion Criteria:\n\n1. Patients with end-stage renal disease undergoing renal transplantation;\n2. 18-60 years old;\n3. Postoperative follow-up points are complete (visit the hospital every week in the first month after surgery, every two weeks in 2-3 months, every four to six months, and every three months in 7-12 months. Follow up at any time when skin rejection is observed. The follow-up time may be adjusted when the condition changes);\n4. The participants had good compliance, volunteered to participate in the test and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Untreated or disseminated malignant tumor;\n2. Active period of infectious diseases;\n3. Serious cardiovascular disease occurred recently;\n4. Combined with other important organ failure;\n5. History of mental illness or cognitive impairment;","60 Years",{"count":537,"type":22},24,"The purpose of this study was to explore the accuracy of sentinel skin grafts from the same donor source in diagnosing renal allograft rejection, and to provide new ideas and options for the later clinical diagnosis of renal allograft rejection. Further, try to provide timing guidance for early immunization intervention.",[29,540],"Skin Graft","2023-11-27",{"date":543,"type":34},"2023-11-28",{"date":545,"type":22},"2024-01-01",{"date":547,"type":22},"2026-12-31",{"name":549,"class":71},"Second Affiliated Hospital, School of Medicine, Zhejiang University",3]