[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441403":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":47,"studyPopulation":38,"armGroups":48,"interventions":55,"overallOfficials":38,"centralContacts":61,"locations":66,"responsibleParty":179,"collaborators":38,"id":181,"slug":182,"hasResults":183,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":38,"eligibilityCriteria":187,"healthyVolunteers":183,"sex":188,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":38,"studyType":194,"phases":195,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":69,"whyStopped":38,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":221},{"fullName":5,"class":6},"Eledon Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":38,"otherOutcomes":38},[9,13,17,20,23,26,29,32,35],{"measure":10,"description":11,"timeFrame":12},"Safety Incidences","Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)","Through study completion, an average up to 20 months",{"measure":14,"description":15,"timeFrame":16},"Pharmacokinetic- PK profile","PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)","Day 1 and at steady state Month 3",{"measure":18,"description":19,"timeFrame":16},"Pharmacokinetic- Area under the plasma concentration","Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)",{"measure":21,"description":22,"timeFrame":16},"Pharmacokinetic- Cmax","Maximum observed plasma concentration (Cmax)",{"measure":24,"description":25,"timeFrame":16},"Pharmacokinetic- Tmax","Time to reach maximum observed plasma concentration (Tmax)",{"measure":27,"description":28,"timeFrame":16},"Pharmacokinetic- Ke","Terminal elimination rate constant (Ke)",{"measure":30,"description":31,"timeFrame":16},"Pharmacokinetic- (t1\u002F2)","Terminal phase half-life (t1\u002F2)",{"measure":33,"description":34,"timeFrame":16},"Pharmacokinetic- CL","Clearance (CL)",{"measure":36,"description":37,"timeFrame":16},"Pharmacokinetic- (Vdss)","Volume of distribution at steady state (Vdss)",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"NA","SINGLE_GROUP","Phase 1b, open label, single-arm study","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":38},"NONE","None ( Open Label)","This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.",[49],{"label":50,"type":51,"description":52,"interventionNames":53},"AT-1501 Single Arm","EXPERIMENTAL","AT-1501 monoclonal antibody targeting CD40L given as an IV infusion",[54],"Drug: AT-1501",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":38},"DRUG","AT-1501","Investigative Arm",[50],[62],{"name":5,"role":63,"phone":64,"phoneExt":38,"email":65},"CONTACT","949-238-8090","clinicaltrials@eledon.com",[67,84,98,110,122,136,143,155,168],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"University of Cincinnati","RECRUITING","Cincinnati","Ohio","45267","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-84.51439,39.12711,{"lat":79,"lon":78},[82],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},"Research Staff",{"facility":85,"status":69,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Royal Prince Alfred Hospital","Camperdown","New South Wales","2050","Australia","AU",{"type":76,"coordinates":92},[93,94],151.17642,-33.88965,{"lat":94,"lon":93},[97],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},{"facility":99,"status":69,"city":100,"state":101,"zip":102,"country":89,"countryCode":90,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Royal Adelaide Hospital","Adelaide","South Australia","SA 5000",{"type":76,"coordinates":104},[105,106],138.59863,-34.92866,{"lat":106,"lon":105},[109],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},{"facility":111,"status":69,"city":112,"state":38,"zip":38,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Fundação Oswaldo Ramos - Hospital do Rim","São Paulo","Brazil","BR",{"type":76,"coordinates":116},[117,118],-46.63611,-23.5475,{"lat":118,"lon":117},[121],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},{"facility":123,"status":69,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Providence Health Care - St. Paul's Hospital","Vancouver","British Columbia","V6Z 1Y6","Canada","CA",{"type":76,"coordinates":130},[131,132],-123.11934,49.24966,{"lat":132,"lon":131},[135],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},{"facility":137,"status":69,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":138,"geoPoint":140,"contacts":141},"Vancouver General Hospital",{"type":76,"coordinates":139},[131,132],{"lat":132,"lon":131},[142],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},{"facility":144,"status":69,"city":145,"state":146,"zip":147,"country":127,"countryCode":128,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"McGill University Health Care Centre","Montreal","Quebec","H4A 3J1",{"type":76,"coordinates":149},[150,151],-73.58781,45.50884,{"lat":151,"lon":150},[154],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},{"facility":156,"status":69,"city":157,"state":38,"zip":158,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital","Liverpool","L78XP","United Kingdom","UK",{"type":76,"coordinates":162},[163,164],-2.97794,53.41058,{"lat":164,"lon":163},[167],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},{"facility":169,"status":69,"city":170,"state":38,"zip":171,"country":159,"countryCode":160,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital","Oxford","OX3 9DU",{"type":76,"coordinates":173},[174,175],-1.25596,51.75222,{"lat":175,"lon":174},[178],{"name":83,"role":63,"phone":38,"phoneExt":38,"email":38},{"type":180,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100441403","phase-1-safety-pharmacokinetics-and-efficacy-of-at-1501-in-patients-undergoing-kidney-transplant-100441403",false,"NCT05027906","Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant","A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant","Inclusion Criteria:\n\n1. Male or female ≥ 18 years of age\n2. Recipient of their first kidney transplant from a living or deceased donor\n3. Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug\n\nExclusion Criteria:\n\n1. Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen\n2. Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily;\n3. Previous treatment with AT 1501 or any other anti CD40LG therapy\n4. The patient has previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant\n5. Will receive a kidney with an anticipated cold ischemia time of \\> 30 hours;\n6. Will receive a kidney from a donor that meets any of the following criteria:\n\n   * Donation after Cardiac Death (DCD) criteria; or\n   * Extended Criteria Donor (ECD) criteria, defined as:\n   * Is blood group (ABO) incompatible; or\n   * Age ≥ 60 years; or Age 50-59 years with any 2 of the following criteria:\n   * Death due to cerebrovascular accident\n   * History of hypertension\n   * Terminal creatinine ≥ 133 μmol\u002FL (1.5 mg\u002FdL)\n7. Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor\n8. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day\n9. History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation:\n10. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening","ALL","18 Years","100 Years",{"count":192,"type":193},48,"ESTIMATED","INTERVENTIONAL",[196,197],"PHASE1","PHASE2","This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.",[200],"Prevention of Rejection in Kidney Transplant",[202,203,204,58,205,206,207,208,209,210,211],"Kidney Transplant","Renal Allograft Rejection","Prophylaxis","CD40L inhibitor","Humanized blocking antibody to CD40L","Monoclonal Antibody","Renal","Transplant","ESRD","tegoprubart","2025-06-25",{"date":214,"type":215},"2025-06-29","ACTUAL",{"date":217,"type":215},"2022-02-18",{"date":219,"type":193},"2027-01",{"name":5,"class":6},9]