[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alloimmunization\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alloimmunization":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"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":35,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100640982","phase-1-immunological-reset-to-enable-access-to-hla-compatible-kidney-transplantation-in-highly-sensitized-patients-reset-100640982",false,"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.","ALL","18 Years","60 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","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.",[29,30,31,32,33,34],"Kidney Failure, Chronic","Kidney Transplantation","Alloimmunization","HLA Sensitization","End Stage Cronic Kidney Disease","Highly Sensitized Patients Awaiting Kidney Transplant",[36,37,30,38,39,40,41,42,43,44,45],"Autologous Hematopoietic Stem Cell Transplantation","AHSCT","Highly sensitized","Hyperimmunized","Desensitization","Anti-HLA Antibodies","CD34+ Cells","Transplant Immunology","End-Stage Kidney Disease","Immune Reset","RECRUITING","2026-06-02",{"date":49,"type":50},"2026-06-04","ACTUAL",{"date":52,"type":50},"2024-02-01",{"date":54,"type":22},"2028-06",{"name":56,"class":57},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":4,"briefSummary":71,"conditions":72,"keywords":85,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":58},"100624813","hemophilia-a-research-program-100624813","NCT07414511","Hemophilia A Research Program","Hemophilia A Research Program (HARP): An Observational Intergenerational Cohort Study of Hemophilia A and Factor VIII Immunogenicity","HARP","Maternal Inclusion Criteria:\n\nPregnant individuals who meet the following criteria are eligible for enrollment as study participants:\n\n* Currently pregnant and prior to 37 weeks gestation\n* Known to have or at-risk of having a severe hemophilia A genotype\n* Pregnant with at least one fetus at-risk of inheriting severe hemophilia A\n* Ability to understand and willingness to provide informed consent\n* 18 years of age or older\n\nBefore the 38th week of pregnancy, enrolled participants must meet all the following criteria to continue to remain in the study:\n\n* The pregnant mother has a severe hemophilia A genotype.\n* A fetus is determined to have a \\>\u002F= 25% risk of inheriting severe hemophilia A, or prenatal testing indicates a fetus is affected by severe hemophilia A.\n* No other discontinuation criteria have been identified.\n\nPediatric Continuation \u002F Inclusion Criteria:\n\nEligibility of the child to continue is assessed by age 8 weeks. Mother-child pairs in which a child meets the following criteria will remain in the study:\n\n* Severe hemophilia A defined by a baseline FVIII:C \\\u003C 0.01 IU\u002FmL (or FVIII:C \\\u003C 1%) or a genotype predicted to cause severe hemophilia A\n* Born to a mother participating in the study\n\nThereafter, mothers and their children will continue in the study as long as no new discontinuation criteria occur.\n\nInclusion Criteria for Blood Relatives:\n\nBlood relatives of the child may be offered participation if one of the following criteria are met:\n\n* First-degree blood relatives (e.g., father, sibling) of the child\n* Second-degree blood relatives (e.g., aunt, uncle, grandparent, half-sibling) of the child\n* Any more distant male or female blood relative whose data or samples may be informative for the planned genetic studies of hemophilia and inhibitors\n\nExclusion\u002FDiscontinuation Criteria:\n\nMaternal: For the pregnant person, exclusion or discontinuation criteria are as follows:\n\n* Genetic testing is negative for a severe hemophilia A genotype\n* Prenatal clinical diagnostic testing that indicates there is no fetus affected with severe hemophilia A\n* Presence of another clinically significant bleeding disorder\n* Participation in another study for which any blood collection total would exceed safety limits defined in this study\n* Will deliver outside the United States or plans for regular pediatric care for the child to be delivered outside the United States\n* Is a prisoner\n* Any other reason that, in the opinion of the investigator, would render the individual unsuitable for participation in the study\n* Inability for study team to obtain translated study documents in time for participation if participant is not fluent in English\n\nPediatric: For the child, discontinuation criteria are as follows:\n\n* Infant does not have severe hemophilia A defined by a baseline FVIII:C \\\u003C 0.01 IU\u002FmL (or FVIII:C \\\u003C 1%) or does not have a genotype predicted to cause severe hemophilia A\n* Mother or child did not have minimal required study samples or data collected before birth, around the time of delivery, or in the neonatal period\n* Child has another clinically significant bleeding disorder\n* Child has a clinically severe immune disorder\n* Participation in another study for which any blood collection total would exceed safety limits defined in this study\n* Any other reason that, in the opinion of the investigator, would render the individual unsuitable for participation in the study",true,{"count":69,"type":22},500,"OBSERVATIONAL","This study longitudinally observes the intergenerational (mother-child) continuum in hemophilia A from pregnancy through early childhood. Because the study follows mother-child pairs, the study includes both a maternal cohort and a pediatric cohort. Each cohort has a primary goal: for the mother with a severe hemophilia genotype, the overarching primary goal is to understand the risks for pregnancy-associated bleeding and postpartum hemorrhage (PPH); for the child, the overarching primary goal is to understand the risks, timing, and circumstances of development of anti-FVIII antibodies. From a longitudinal perspective, risks for both bleeding in the mother and anti-FVIII antibody development in the child are expected to be influenced over time by genetic and environmental factors that begin early in (or before) pregnancy. Enrollment of blood relatives is offered to improve power to better understand inherited contributions to bleeding and inhibitor development in the mother-baby pairs.",[73,74,75,76,77,78,79,80,81,82,83,31,84],"Hemophilia A","Hemophilia A, Severe","Factor VIII (FVIII)","FVIII Deficiency","Carrier of Hemophilia A","Inhibitors","Pregnancy","Maternal Blood Loss","Pregnancy Complications","Bleeding Disorder","Hemorrhage, Postpartum","X-Linked",[79,86,87,82,88,89,73,90,91,92,93],"Inhibitor","Bleeding","Maternal Child Health","Hemophilia","Hemophilia A Carrier","Hemophilia A Symptomatic Carrier","Coagulation","Factor VIII","2026-02-09",{"date":96,"type":50},"2026-02-17",{"date":98,"type":50},"2024-07-31",{"date":100,"type":22},"2029-08",{"name":102,"class":57},"University of Washington"]