[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464231":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":293,"collaborators":30,"id":295,"slug":296,"hasResults":297,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":297,"sex":303,"minAge":304,"maxAge":30,"enrollmentInfo":305,"targetDuration":30,"studyType":308,"phases":309,"briefSummary":311,"conditions":312,"keywords":316,"overallStatus":48,"whyStopped":30,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},{"fullName":5,"class":6},"The University of Queensland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immunosuppression reduction\u002Fmodification + Intravenous Immunoglobulin","EXPERIMENTAL","Receives Immunosuppression reduction\u002Fmodification + Intravenous Immunoglobulin",[13],"Drug: Immunosuppression reduction\u002Fmodification + intravenous immunoglobulin",{"label":15,"type":6,"description":16,"interventionNames":17},"Immunosuppression reduction\u002Fmodification","Receives Immunosuppression reduction\u002Fmodification as part of standard of care.",[18],"Other: Immunosuppression reduction\u002Fmodification",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Immunosuppression reduction\u002Fmodification + intravenous immunoglobulin","Participants will receive intravenous immunoglobulin along with immunosuppression reduction\u002Fmodification.",[9],[26],"Human immunoglobulin",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Participants will receive immunosuppression reduction\u002Fmodification.",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Germaine Wong, Professor","University of Sydney","STUDY_CHAIR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Misa Matsuyama, PhD","CONTACT","+61 437 759 894","beat-bk@uq.edu.au",{"name":43,"role":39,"phone":44,"phoneExt":30,"email":41},"Pushparaj Velayudham","+61 438 077 278",[46,72,95,117,136,148,168,183,205,226,245,266,282],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Canberra Hospital","RECRUITING","Canberra","Australian Capital Territory","2605","Australia","AU",{"type":55,"coordinates":56},"Point",[57,58],149.12807,-35.28346,{"lat":58,"lon":57},[61,65,69],{"name":62,"role":39,"phone":63,"phoneExt":30,"email":64},"Andrea Blanco","02 5124 2146","Andrea.Blanco@act.gov.au",{"name":66,"role":39,"phone":67,"phoneExt":30,"email":68},"Lizanne Mackintosh","02 5124 2526","Lizanne.Mackintosh@act.gov.au",{"name":70,"role":71,"phone":30,"phoneExt":30,"email":30},"Krishna Karpe, Dr","PRINCIPAL_INVESTIGATOR",{"facility":73,"status":48,"city":74,"state":75,"zip":76,"country":52,"countryCode":53,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"John Hunter Hospital","New Lambton Heights","New South Wales","2305",{"type":55,"coordinates":78},[79,80],151.69364,-32.92466,{"lat":80,"lon":79},[83,87,90,92],{"name":84,"role":39,"phone":85,"phoneExt":30,"email":86},"Denise Jones","02 4921 4332","Denise.jones@health.nsw.gov.au",{"name":88,"role":39,"phone":85,"phoneExt":30,"email":89},"Melissa Mulholland","Melissa.Mulholland@health.nsw.gov.au",{"name":91,"role":71,"phone":30,"phoneExt":30,"email":30},"Thida Myint, Dr",{"name":93,"role":94,"phone":30,"phoneExt":30,"email":30},"Eswari Vilayur, Dr","SUB_INVESTIGATOR",{"facility":96,"status":48,"city":97,"state":75,"zip":98,"country":52,"countryCode":53,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Prince of Wales Hospital","Randwick","2031",{"type":55,"coordinates":100},[101,102],151.24895,-33.91439,{"lat":102,"lon":101},[105,109,113,115],{"name":106,"role":39,"phone":107,"phoneExt":30,"email":108},"Jacquiline Pearse","(02) 9382 4444","Jacqueline.Pearse@health.nsw.gov.au",{"name":110,"role":39,"phone":111,"phoneExt":30,"email":112},"Hannah Kim","(02) 9382 4418","Jong.Kim1@health.nsw.gov.au",{"name":114,"role":71,"phone":30,"phoneExt":30,"email":30},"Karen Keung, Dr",{"name":116,"role":94,"phone":30,"phoneExt":30,"email":30},"Kenneth Yong, Dr",{"facility":118,"status":48,"city":119,"state":75,"zip":120,"country":52,"countryCode":53,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Royal Prince Alfred Hospital","Sydney","2050",{"type":55,"coordinates":122},[123,124],151.20732,-33.86785,{"lat":124,"lon":123},[127,131,134],{"name":128,"role":39,"phone":129,"phoneExt":30,"email":130},"Christina Gong","61 2 9515 4980","christina.gong@health.nsw.gov.au",{"name":132,"role":39,"phone":129,"phoneExt":30,"email":133},"Lin Lin","Lin.Lin1@health.nsw.gov.au",{"name":135,"role":71,"phone":30,"phoneExt":30,"email":30},"Kate Wyburn, A\u002FProf",{"facility":137,"status":48,"city":119,"state":75,"zip":138,"country":52,"countryCode":53,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"The Childrens Hospital Westmead","2145",{"type":55,"coordinates":140},[123,124],{"lat":124,"lon":123},[143,147],{"name":144,"role":39,"phone":145,"phoneExt":30,"email":146},"Siah Kim, Dr","+61 421454723","siah.kim@health.nsw.gov.au",{"name":144,"role":71,"phone":30,"phoneExt":30,"email":30},{"facility":149,"status":48,"city":150,"state":75,"zip":138,"country":52,"countryCode":53,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Western Sydney Local Health District (Westmead Hospital)","Westmead",{"type":55,"coordinates":152},[153,154],150.98768,-33.80383,{"lat":154,"lon":153},[157,161,165,166],{"name":158,"role":39,"phone":159,"phoneExt":30,"email":160},"Penelope Murrie","02 8890 6848","Penelope.Murie@health.nsw.gov.au",{"name":162,"role":39,"phone":163,"phoneExt":30,"email":164},"Sana Hamilton","02 8890 3883","sana.hamilton@health.nsw.gov.au",{"name":33,"role":71,"phone":30,"phoneExt":30,"email":30},{"name":167,"role":94,"phone":30,"phoneExt":30,"email":30},"Dharshana Sabanayagam, Doctor",{"facility":169,"status":48,"city":170,"state":171,"zip":172,"country":52,"countryCode":53,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Queensland Children's Hospital","Brisbane","Queensland","4101",{"type":55,"coordinates":174},[175,176],153.02809,-27.46794,{"lat":176,"lon":175},[179,181],{"name":180,"role":39,"phone":30,"phoneExt":30,"email":30},"Sophie Anderson-James",{"name":182,"role":71,"phone":30,"phoneExt":30,"email":30},"Anna Francis, Dr",{"facility":184,"status":48,"city":185,"state":171,"zip":186,"country":52,"countryCode":53,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Townsville University Hospital","Townsville","4814",{"type":55,"coordinates":188},[189,190],146.80569,-19.26639,{"lat":190,"lon":189},[193,196,199,201,203],{"name":194,"role":39,"phone":30,"phoneExt":30,"email":195},"Belinda Elford","Belinda.Elford@health.qld.gov.au",{"name":197,"role":39,"phone":30,"phoneExt":30,"email":198},"Jennifer King","Jennifer.King2@health.qld.gov.au",{"name":200,"role":71,"phone":30,"phoneExt":30,"email":30},"Vikas Srivastava, Dr",{"name":202,"role":94,"phone":30,"phoneExt":30,"email":30},"Michelle Hartfield, Dr",{"name":204,"role":94,"phone":30,"phoneExt":30,"email":30},"Mohandas Janaki Tapasya, Dr",{"facility":206,"status":48,"city":207,"state":171,"zip":208,"country":52,"countryCode":53,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Princess Alexandra Hospital","Woolloongabba","4102",{"type":55,"coordinates":210},[211,212],153.03655,-27.48855,{"lat":212,"lon":211},[215,219,222,224],{"name":216,"role":39,"phone":217,"phoneExt":30,"email":218},"Rachael Hale","07 3176 6325","Rachael.Hale@health.qld.gov.au",{"name":220,"role":39,"phone":217,"phoneExt":30,"email":221},"Diana Leary","Diana.leary@health.qld.gov.au",{"name":223,"role":71,"phone":30,"phoneExt":30,"email":30},"Samantha Ng, Dr",{"name":225,"role":94,"phone":30,"phoneExt":30,"email":30},"Ross Francis, Dr",{"facility":227,"status":48,"city":228,"state":229,"zip":230,"country":52,"countryCode":53,"cosmosGeoPoint":231,"geoPoint":235,"contacts":236},"Flinders Medical Centre","Adelaide","South Australia","5042",{"type":55,"coordinates":232},[233,234],138.59863,-34.92866,{"lat":234,"lon":233},[237,241,243],{"name":238,"role":39,"phone":239,"phoneExt":30,"email":240},"Merin Kuriakose, CN","(08) 8204 6281","Merin.Kuriakose@sa.gov.au",{"name":242,"role":39,"phone":239,"phoneExt":30,"email":30},"CN",{"name":244,"role":71,"phone":30,"phoneExt":30,"email":30},"Rajiv Juneja, Dr",{"facility":246,"status":48,"city":247,"state":248,"zip":249,"country":52,"countryCode":53,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"Monash Health","Melbourne","Victoria","3168",{"type":55,"coordinates":251},[252,253],144.96332,-37.814,{"lat":253,"lon":252},[256,260,264],{"name":257,"role":39,"phone":258,"phoneExt":30,"email":259},"Rita Barbis","03 9594 3523","rita.barbis@monashhealth.org",{"name":261,"role":39,"phone":262,"phoneExt":30,"email":263},"Laura Chen","03 9594 3049","laura.chen2@monashhealth.org",{"name":265,"role":71,"phone":30,"phoneExt":30,"email":30},"John Kanellis, Prof",{"facility":267,"status":48,"city":268,"state":269,"zip":270,"country":52,"countryCode":53,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"Perth Children's Hospital","Perth","Western Australia","6009",{"type":55,"coordinates":272},[273,274],115.8614,-31.95224,{"lat":274,"lon":273},[277,281],{"name":278,"role":39,"phone":279,"phoneExt":30,"email":280},"Nick Larkins, Dr","+61 8 6456 2222","Nicholas.Larkins@health.wa.gov.au",{"name":278,"role":71,"phone":30,"phoneExt":30,"email":30},{"facility":283,"status":48,"city":268,"state":269,"zip":270,"country":52,"countryCode":53,"cosmosGeoPoint":284,"geoPoint":286,"contacts":287},"Sir Charles Gairdner Hospital",{"type":55,"coordinates":285},[273,274],{"lat":274,"lon":273},[288,292],{"name":289,"role":39,"phone":290,"phoneExt":30,"email":291},"Wai Lim, Prof","+61 8 6457 3333","wai.lim@health.wa.gov.au",{"name":289,"role":71,"phone":30,"phoneExt":30,"email":30},{"type":294,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100464231","phase-3-a-trial-to-treat-polyomavirus-infections-bkpyv-in-kidney-and-simultaneous-kidney-pancreas-transplant-recipients-100464231",false,"NCT05325008","A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients","An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients","BEAT-BK","Inclusion Criteria:\n\n1. Aged 2 years or above\n2. Have received a kidney or simultaneous pancreas-kidney transplant\n3. Have BKPyV-Viremia (detected by RT-PCR) with a viral count ≥ 5,000 copies per mL, or histological confirmation of BKPyVAN, within 3 weeks prior to randomisation.\n4. Be able to provide informed consent or consent given by a parent or guardian (if age \\\u003C18 years) or other authorised person\n\nExclusion Criteria:\n\n1. Contraindications to receiving IVIG as a treatment\n2. Current active acute rejection (≤ 3 months prior)\n3. Treating clinicians would regard as unsafe to be enrolled\n4. Limited life expectancy (\\\u003C 12 months)\n5. Receiving Belatacept as part of their immunosuppression protocol\n6. Currently undergoing or who have previously received, viral-specific T-cell therapy for BK viremia\n7. Prior infection and treatment for BKPyV-Viremia\n8. Received IVIG treatment in the past with last IVIG treatment \\\u003C 4 weeks prior to randomisation","ALL","2 Years",{"count":306,"type":307},280,"ESTIMATED","INTERVENTIONAL",[310],"PHASE3","BEAT-BK will see the effect of immunosuppression reduction\u002Fmodification with and without IVIG on BKPyV infection, allograft function, allograft loss, acute transplant rejection, immunosuppression load and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV).",[313,314,315],"BK Viremia","Kidney Transplant Infection","Kidney Transplant Failure and Rejection",[317,318,319,320,321,322],"Kidney transplantation","Intravenous immunoglobulin","Virus","Nephropathy","Clinical trial","Nephrology","2026-06-05",{"date":325,"type":326},"2026-06-08","ACTUAL",{"date":328,"type":326},"2023-08-18",{"date":330,"type":307},"2029-06-30",{"name":5,"class":6},13]