[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100302799":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":28,"locations":33,"responsibleParty":285,"collaborators":28,"id":287,"slug":288,"hasResults":289,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":28,"eligibilityCriteria":293,"healthyVolunteers":294,"sex":295,"minAge":296,"maxAge":28,"enrollmentInfo":297,"targetDuration":28,"studyType":300,"phases":301,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":309,"whyStopped":310,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},{"fullName":5,"class":6},"CSL Behring","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"C1-INH","EXPERIMENTAL","C1-esterase inhibitor",[13],"Drug: C1-esterase inhibitor",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Excipients of C1-INH plus albumin",[19],"Drug: Placebo",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution",[9],[9],{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":28},[15],null,[30],{"name":31,"affiliation":5,"role":32},"Program Director","STUDY_DIRECTOR",[34,47,57,67,77,87,97,107,117,126,132,142,152,162,173,184,193,202,211,220,226,235,246,257,268,274],{"facility":35,"status":28,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":28},"University of Alabama Hospital (at Birmingham)","Birmingham","Alabama","35233","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-86.80249,33.52066,{"lat":45,"lon":44},{"facility":48,"status":28,"city":49,"state":50,"zip":51,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":56,"contacts":28},"Mayo Clinic Arizona","Phoenix","Arizona","85054",{"type":42,"coordinates":53},[54,55],-112.07404,33.44838,{"lat":55,"lon":54},{"facility":58,"status":28,"city":59,"state":60,"zip":61,"country":39,"countryCode":40,"cosmosGeoPoint":62,"geoPoint":66,"contacts":28},"California Pacific","San Francisco","California","94115",{"type":42,"coordinates":63},[64,65],-122.41942,37.77493,{"lat":65,"lon":64},{"facility":68,"status":28,"city":69,"state":70,"zip":71,"country":39,"countryCode":40,"cosmosGeoPoint":72,"geoPoint":76,"contacts":28},"Yale New Haven Hospital","New Haven","Connecticut","06520",{"type":42,"coordinates":73},[74,75],-72.92816,41.30815,{"lat":75,"lon":74},{"facility":78,"status":28,"city":79,"state":80,"zip":81,"country":39,"countryCode":40,"cosmosGeoPoint":82,"geoPoint":86,"contacts":28},"University of Illinois Chicago","Chicago","Illinois","60612",{"type":42,"coordinates":83},[84,85],-87.65005,41.85003,{"lat":85,"lon":84},{"facility":88,"status":28,"city":89,"state":90,"zip":91,"country":39,"countryCode":40,"cosmosGeoPoint":92,"geoPoint":96,"contacts":28},"Brigham & Women's","Boston","Massachusetts","02115",{"type":42,"coordinates":93},[94,95],-71.05977,42.35843,{"lat":95,"lon":94},{"facility":98,"status":28,"city":99,"state":100,"zip":101,"country":39,"countryCode":40,"cosmosGeoPoint":102,"geoPoint":106,"contacts":28},"Mayo Clinic (Rochester)","Rochester","Minnesota","55905",{"type":42,"coordinates":103},[104,105],-92.4699,44.02163,{"lat":105,"lon":104},{"facility":108,"status":28,"city":109,"state":110,"zip":111,"country":39,"countryCode":40,"cosmosGeoPoint":112,"geoPoint":116,"contacts":28},"St. Barnabas Medical Center","Livingston","New Jersey","07039",{"type":42,"coordinates":113},[114,115],-74.31487,40.79593,{"lat":115,"lon":114},{"facility":118,"status":28,"city":119,"state":119,"zip":120,"country":39,"countryCode":40,"cosmosGeoPoint":121,"geoPoint":125,"contacts":28},"NYU","New York","10016",{"type":42,"coordinates":122},[123,124],-74.00597,40.71427,{"lat":124,"lon":123},{"facility":127,"status":28,"city":119,"state":119,"zip":128,"country":39,"countryCode":40,"cosmosGeoPoint":129,"geoPoint":131,"contacts":28},"Columbia University","10032",{"type":42,"coordinates":130},[123,124],{"lat":124,"lon":123},{"facility":133,"status":28,"city":134,"state":135,"zip":136,"country":39,"countryCode":40,"cosmosGeoPoint":137,"geoPoint":141,"contacts":28},"Vanderbilt University","Nashville","Tennessee","37232",{"type":42,"coordinates":138},[139,140],-86.78444,36.16589,{"lat":140,"lon":139},{"facility":143,"status":28,"city":144,"state":145,"zip":146,"country":39,"countryCode":40,"cosmosGeoPoint":147,"geoPoint":151,"contacts":28},"Houston Methodist","Houston","Texas","77030",{"type":42,"coordinates":148},[149,150],-95.36327,29.76328,{"lat":150,"lon":149},{"facility":153,"status":28,"city":154,"state":155,"zip":156,"country":39,"countryCode":40,"cosmosGeoPoint":157,"geoPoint":161,"contacts":28},"University of Wisconsin","Madison","Wisconsin","53705-2281",{"type":42,"coordinates":158},[159,160],-89.40123,43.07305,{"lat":160,"lon":159},{"facility":163,"status":28,"city":164,"state":28,"zip":165,"country":166,"countryCode":167,"cosmosGeoPoint":168,"geoPoint":172,"contacts":28},"Universitair Ziekenhuis Gasthuisberg","Leuven","3000","Belgium","BE",{"type":42,"coordinates":169},[170,171],4.70093,50.87959,{"lat":171,"lon":170},{"facility":174,"status":28,"city":175,"state":28,"zip":176,"country":177,"countryCode":178,"cosmosGeoPoint":179,"geoPoint":183,"contacts":28},"CHU de Bordeaux. Hôpital Pellegrin","Bordeaux","33000","France","FR",{"type":42,"coordinates":180},[181,182],-0.58046,44.84124,{"lat":182,"lon":181},{"facility":185,"status":28,"city":186,"state":28,"zip":187,"country":177,"countryCode":178,"cosmosGeoPoint":188,"geoPoint":192,"contacts":28},"CHU de Grenoble - Hôpital Michalon","Grenoble","38043",{"type":42,"coordinates":189},[190,191],5.71479,45.17869,{"lat":191,"lon":190},{"facility":194,"status":28,"city":195,"state":28,"zip":196,"country":177,"countryCode":178,"cosmosGeoPoint":197,"geoPoint":201,"contacts":28},"Centre Regional Hospitalier Universitaire de Lille","Lille","59000",{"type":42,"coordinates":198},[199,200],3.05512,50.63391,{"lat":200,"lon":199},{"facility":203,"status":28,"city":204,"state":28,"zip":205,"country":177,"countryCode":178,"cosmosGeoPoint":206,"geoPoint":210,"contacts":28},"Hospital Edouard Herriot Lyon","Lyon","69003",{"type":42,"coordinates":207},[208,209],4.84789,45.74906,{"lat":209,"lon":208},{"facility":212,"status":28,"city":213,"state":28,"zip":214,"country":177,"countryCode":178,"cosmosGeoPoint":215,"geoPoint":219,"contacts":28},"Hopital saint Louis Paris","Paris","75010",{"type":42,"coordinates":216},[217,218],2.3488,48.85341,{"lat":218,"lon":217},{"facility":221,"status":28,"city":213,"state":28,"zip":222,"country":177,"countryCode":178,"cosmosGeoPoint":223,"geoPoint":225,"contacts":28},"Necker Hospital","75743",{"type":42,"coordinates":224},[217,218],{"lat":218,"lon":217},{"facility":227,"status":28,"city":228,"state":28,"zip":229,"country":177,"countryCode":178,"cosmosGeoPoint":230,"geoPoint":234,"contacts":28},"CHU Rangueil","Toulouse","31059",{"type":42,"coordinates":231},[232,233],1.44367,43.60426,{"lat":233,"lon":232},{"facility":236,"status":28,"city":237,"state":28,"zip":238,"country":239,"countryCode":240,"cosmosGeoPoint":241,"geoPoint":245,"contacts":28},"Charite Berline","Berlin","10117","Germany","DE",{"type":42,"coordinates":242},[243,244],13.41053,52.52437,{"lat":244,"lon":243},{"facility":247,"status":28,"city":248,"state":28,"zip":249,"country":250,"countryCode":251,"cosmosGeoPoint":252,"geoPoint":256,"contacts":28},"Leiden University Medical Center","Leiden","2300","Netherlands","NL",{"type":42,"coordinates":253},[254,255],4.49306,52.15833,{"lat":255,"lon":254},{"facility":258,"status":28,"city":259,"state":28,"zip":260,"country":261,"countryCode":262,"cosmosGeoPoint":263,"geoPoint":267,"contacts":28},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":42,"coordinates":264},[265,266],2.15899,41.38879,{"lat":266,"lon":265},{"facility":269,"status":28,"city":259,"state":28,"zip":270,"country":261,"countryCode":262,"cosmosGeoPoint":271,"geoPoint":273,"contacts":28},"Hospital Clinic de Barcelona","08036",{"type":42,"coordinates":272},[265,266],{"lat":266,"lon":265},{"facility":275,"status":28,"city":276,"state":28,"zip":277,"country":278,"countryCode":279,"cosmosGeoPoint":280,"geoPoint":284,"contacts":28},"Guy's Hospital","London","SE19RT","United Kingdom","UK",{"type":42,"coordinates":281},[282,283],-0.12574,51.50853,{"lat":283,"lon":282},{"type":286,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100302799","phase-3-efficacy-and-safety-of-human-plasma-derived-c1-esterase-inhibitor-as-add-on-to-standard-of-care-for-the-treatment-of-refractory-antibody-mediated-rejection-amr-in-adult-renal-transplant-recipients-100302799",true,"NCT03221842","Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients","A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients","Inclusion Criteria:\n\n* Male or female at least 18 years of age;\n* Evidence of at least one donor-specific antibody (DSA);\n* Recipient of a kidney transplant;\n* Achieved a steady-state, post-transplant eGFR ≥ 40 mL\u002Fmin\u002F1.73 m2 within 60 days of post-transplant OR a 50% increase in urine output with a 50% decrease in serum creatinine over the first 7 days post-transplant in subjects with slow or delayed graft function;\n* Acute AMR.\n\nExclusion Criteria:\n\n* Recipient of an en bloc kidney transplant;\n* Current active hepatitis C virus (HCV) infection;\n* Active bacterial or fungal infection;\n* Ongoing dialysis \\>2 weeks;\n* Known congenital bleeding or coagulopathy disorder;\n* Current cancer or a history of cancer;\n* Female subjects who are pregnant or breast feeding;\n* Male or female subjects who are unwilling to use contraception or who are not surgically sterile.",false,"ALL","18 Years",{"count":298,"type":299},63,"ACTUAL","INTERVENTIONAL",[302],"PHASE3","This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).",[305],"Antibody-mediated Rejection",[307,308],"Antibody-mediated kidney transplant rejection","Renal","TERMINATED","The study was terminated early due to futility of enrolment and not for safety reasons.","2022-07-25",{"date":313,"type":299},"2022-07-29",{"date":315,"type":299},"2017-11-06",{"date":317,"type":299},"2021-01-20",{"name":5,"class":6},26]