[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640982":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":35,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":53,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":85,"overallStatus":38,"whyStopped":53,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous Hematopoietic Stem Cell Transplantation (AHSCT)","EXPERIMENTAL","Participants undergo a non-myeloablative conditioning regimen for intense lymphodepletion consisting of intravenous Rituximab, Cyclophosphamide (adjusted for end-stage renal disease), and Thymoglobulin (rATG). This is followed by peripheral blood stem cell collection via leukapheresis, CD34+ immunomagnetic selection, and the reinfusion of purified autologous CD34+ progenitors (target dose \\>= 3 x 10⁶ cells\u002Fkg). At 6 months post-AHSCT, patients are reactivated on the deceased-donor kidney transplant waiting list.",[13],"Biological: Autologous Hematopoietic Stem Cell Transplantation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Autologous Hematopoietic Stem Cell Transplantation","A comprehensive cell therapy protocol involving intense non-myeloablative lymphodepletion followed by stem cell rescue. The intervention includes sequential intravenous administration of Rituximab, Cyclophosphamide (specifically dose-adjusted for end-stage renal disease), and rabbit Thymoglobulin (rATG). Following conditioning, participants receive an intravenous reinfusion of purified autologous CD34+ hematopoietic progenitor cells collected via peripheral blood leukapheresis at a target dose of \\>= 3 x 10⁶ cells\u002Fkg, with a cryopreserved backup aliquot maintained for safety.",[9],[21,22],"AHSCT","Autologous CD34+ stem cell infusion",[24],{"name":25,"affiliation":26,"role":27},"Oriol Bestard","Hospital Vall d'Hebron","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Oriol Bestard, Nephrologist","CONTACT","34932607400","4661","oriol.bestard@vallhebron.cat",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hospital Universitari Vall d'Hebron","RECRUITING","Barcelona","Catalonia","08035","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],2.15899,41.38879,{"lat":48,"lon":47},[51,52],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"name":30,"role":27,"phone":53,"phoneExt":53,"email":53},null,{"type":55,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[57],{"name":58,"class":6},"Hospital Clinic of Barcelona","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":71,"type":72},10,"ESTIMATED","INTERVENTIONAL",[75,76],"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.",[79,80,81,82,83,84],"Kidney Failure, Chronic","Kidney Transplantation","Alloimmunization","HLA Sensitization","End Stage Cronic Kidney Disease","Highly Sensitized Patients Awaiting Kidney Transplant",[17,21,80,86,87,88,89,90,91,92,93],"Highly sensitized","Hyperimmunized","Desensitization","Anti-HLA Antibodies","CD34+ Cells","Transplant Immunology","End-Stage Kidney Disease","Immune Reset","2026-06-02",{"date":96,"type":97},"2026-06-04","ACTUAL",{"date":99,"type":97},"2024-02-01",{"date":101,"type":72},"2028-06",{"name":5,"class":6},1]