[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552529":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":41,"centralContacts":48,"locations":54,"responsibleParty":353,"collaborators":355,"id":357,"slug":358,"hasResults":359,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":40,"eligibilityCriteria":363,"healthyVolunteers":359,"sex":364,"minAge":365,"maxAge":40,"enrollmentInfo":366,"targetDuration":40,"studyType":369,"phases":370,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":98,"whyStopped":40,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":387},{"fullName":5,"class":6},"University of Sydney","OTHER",[8,15,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Lower dose IV methylprednisolone x Lower dose oral prednisone","EXPERIMENTAL","Lower dose IV MP (250 mg daily x 3 days in adults or 150 mg\u002Fm² daily x 3, or to a max 250 mg\u002Fdose in children (\\\u003C18 years), with lower dose (25mg daily x 7 days, or 15mg\u002Fm² for those \\\u003C 18 years ) oral prednisone augmentation then return to standard prednisone.",[13,14],"Drug: Methylprednisolone","Drug: Prednisone",{"label":16,"type":10,"description":17,"interventionNames":18},"Lower dose IV methylprednisolone x Higher dose oral prednisone","Lower dose IV MP (250 mg daily x 3 in adults or 150 mg\u002Fm² daily x 3, or to a max 250 mg\u002Fdose in children (\\\u003C18 years), with higher dose (50mg daily x 7 , or 30mg\u002Fm² daily x 7 for those \\\u003C 18 years) oral prednisone augmentation then return to standard prednisone.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Higher dose IV methylprednisolone x lower dose oral prednisone","ACTIVE_COMPARATOR","Higher dose IV MP (500mg daily x 3 in adults or 300 mg\u002Fm² daily x 3 or to a max 500 mg\u002Fdose in children (\\\u003C18 years), with lower dose (25mg daily x 7 days, or 15mg\u002Fm² for those \\\u003C 18 years) oral prednisone augmentation then return to standard prednisone.",[13,14],{"label":25,"type":21,"description":26,"interventionNames":27},"Higher dose IV methylprednisolone x higher dose oral prednisone","Higher dose IV MP (500 mg daily x 3 in adults or 300 mg\u002Fm² daily x 3 or to a max 500 mg\u002Fdose in children (\\\u003C18 years), with higher dose (50mg daily x 7 days, or 30mg\u002Fm² for those \\\u003C 18 years) oral prednisone augmentation, then return to standard prednisone.",[13,14],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Methylprednisolone","IV Methylprednisolone",[25,20,16,9],[35],"IV MP",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Prednisone","Oral prednisone augmentation",[25,20,16,9],null,[42,45],{"name":43,"affiliation":5,"role":44},"Germaine Wong, PhD, FRACP","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":47,"role":44},"Julie Ho, FRCPC","University of Manitoba",[49],{"name":50,"role":51,"phone":52,"phoneExt":40,"email":53},"NHMRC Clinical Trials Centre THE UNIVERSITY OF SYDNEY","CONTACT","+61 2 9562 5000","tackle-it.study@sydney.edu.au",[55,72,84,96,105,118,130,143,158,171,179,191,206,215,227,235,248,261,273,282,291,304,313,325,338],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"John Hunter Hospital","NOT_YET_RECRUITING","Lambton","New South Wales","2305","Australia","AU",{"type":64,"coordinates":65},"Point",[66,67],151.7,-32.91667,{"lat":67,"lon":66},[70],{"name":71,"role":44,"phone":40,"phoneExt":40,"email":40},"Thida Myint, FRACP",{"facility":73,"status":57,"city":74,"state":59,"zip":75,"country":61,"countryCode":62,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Prince of Wales Hospital","Randwick","2031",{"type":64,"coordinates":77},[78,79],151.24895,-33.91439,{"lat":79,"lon":78},[82],{"name":83,"role":44,"phone":40,"phoneExt":40,"email":40},"Kenneth Yong, FRACP, PhD",{"facility":85,"status":57,"city":86,"state":59,"zip":87,"country":61,"countryCode":62,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"The Sydney Children's Hospital Network","Westmead","2145",{"type":64,"coordinates":89},[90,91],150.98768,-33.80383,{"lat":91,"lon":90},[94],{"name":95,"role":44,"phone":40,"phoneExt":40,"email":40},"Siah Kim, FRACP, PhD",{"facility":97,"status":98,"city":86,"state":59,"zip":87,"country":61,"countryCode":62,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Westmead Hospital","RECRUITING",{"type":64,"coordinates":100},[90,91],{"lat":91,"lon":90},[103],{"name":104,"role":44,"phone":40,"phoneExt":40,"email":40},"Germaine Wong, FRACP, Phd",{"facility":106,"status":98,"city":107,"state":108,"zip":109,"country":61,"countryCode":62,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Queensland Children's Hospital","South Brisbane","Queensland","2014",{"type":64,"coordinates":111},[112,113],153.02049,-27.48034,{"lat":113,"lon":112},[116],{"name":117,"role":44,"phone":40,"phoneExt":40,"email":40},"Anna Francis, PhD, FRACP",{"facility":119,"status":57,"city":120,"state":108,"zip":121,"country":61,"countryCode":62,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Princess Alexandra Hospital","Woolloongabba","4102",{"type":64,"coordinates":123},[124,125],153.03655,-27.48855,{"lat":125,"lon":124},[128],{"name":129,"role":44,"phone":40,"phoneExt":40,"email":40},"Carmel Hawley, FRACP, MMSc",{"facility":131,"status":57,"city":132,"state":133,"zip":134,"country":61,"countryCode":62,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":64,"coordinates":136},[137,138],138.59863,-34.92866,{"lat":138,"lon":137},[141],{"name":142,"role":44,"phone":40,"phoneExt":40,"email":40},"Michael Collins, FRACP, PhD",{"facility":144,"status":57,"city":145,"state":146,"zip":147,"country":61,"countryCode":62,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Monash Medical Centre","Clayton","Victoria","3168",{"type":64,"coordinates":149},[150,151],145.11667,-37.91667,{"lat":151,"lon":150},[154,156],{"name":155,"role":44,"phone":40,"phoneExt":40,"email":40},"John Kanellis, FRACP, PhD",{"name":157,"role":44,"phone":40,"phoneExt":40,"email":40},"William Mulley, FRACP, PhD",{"facility":159,"status":57,"city":160,"state":161,"zip":162,"country":61,"countryCode":62,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Royal Perth Children's hospital","Nedlands","Western Australia","6009",{"type":64,"coordinates":164},[165,166],115.8073,-31.98184,{"lat":166,"lon":165},[169],{"name":170,"role":44,"phone":40,"phoneExt":40,"email":40},"Nick Larkins, FRACP, PhD",{"facility":172,"status":57,"city":160,"state":161,"zip":162,"country":61,"countryCode":62,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"Sir Charles Gairdner Hospital",{"type":64,"coordinates":174},[165,166],{"lat":166,"lon":165},[177],{"name":178,"role":44,"phone":40,"phoneExt":40,"email":40},"Wai Lim, FRACP, PHD",{"facility":180,"status":57,"city":181,"state":161,"zip":182,"country":61,"countryCode":62,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Royal Perth Hospital","Perth","6000",{"type":64,"coordinates":184},[185,186],115.8614,-31.95224,{"lat":186,"lon":185},[189],{"name":190,"role":44,"phone":40,"phoneExt":40,"email":40},"Mark Thomas, FRACP",{"facility":192,"status":57,"city":193,"state":194,"zip":195,"country":196,"countryCode":197,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"University of Calgary","Calgary","Alberta","T2N 1N4","Canada","CA",{"type":64,"coordinates":199},[200,201],-114.08529,51.05011,{"lat":201,"lon":200},[204],{"name":205,"role":44,"phone":40,"phoneExt":40,"email":40},"Ngan Lam, MD, MSc",{"facility":207,"status":57,"city":208,"state":194,"zip":209,"country":196,"countryCode":197,"cosmosGeoPoint":210,"geoPoint":214,"contacts":40},"University of Alberta","Edmonton","T6G 2R3",{"type":64,"coordinates":211},[212,213],-113.46871,53.55014,{"lat":213,"lon":212},{"facility":216,"status":57,"city":217,"state":218,"zip":219,"country":196,"countryCode":197,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Transplant Manitoba, adult","Winnipeg","Manitoba","R3A 1R9",{"type":64,"coordinates":221},[222,223],-97.14704,49.8844,{"lat":223,"lon":222},[226],{"name":46,"role":44,"phone":40,"phoneExt":40,"email":40},{"facility":228,"status":57,"city":217,"state":218,"zip":219,"country":196,"countryCode":197,"cosmosGeoPoint":229,"geoPoint":231,"contacts":232},"Transplant Manitoba, pediatric",{"type":64,"coordinates":230},[222,223],{"lat":223,"lon":222},[233],{"name":234,"role":44,"phone":40,"phoneExt":40,"email":40},"Aviva Goldberg, MD",{"facility":236,"status":57,"city":237,"state":238,"zip":239,"country":196,"countryCode":197,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Dalhousie University","Halifax","Nova Scotia","B3H 4R2",{"type":64,"coordinates":241},[242,243],-63.57688,44.64269,{"lat":243,"lon":242},[246],{"name":247,"role":44,"phone":40,"phoneExt":40,"email":40},"Amanda Vinson, MD",{"facility":249,"status":57,"city":250,"state":251,"zip":252,"country":196,"countryCode":197,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Western University","London","Ontario","N6A 3K7",{"type":64,"coordinates":254},[255,256],-81.23304,42.98339,{"lat":256,"lon":255},[259],{"name":260,"role":44,"phone":40,"phoneExt":40,"email":40},"Matthew Weir, MD, FRCPC",{"facility":262,"status":57,"city":263,"state":251,"zip":264,"country":196,"countryCode":197,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"University of Toronto - St Michael Hospital","Toronto","M5B 1W8",{"type":64,"coordinates":266},[267,268],-79.39864,43.70643,{"lat":268,"lon":267},[271],{"name":272,"role":44,"phone":40,"phoneExt":40,"email":40},"Darren Yuen, MD, PhD",{"facility":274,"status":57,"city":263,"state":251,"zip":275,"country":196,"countryCode":197,"cosmosGeoPoint":276,"geoPoint":278,"contacts":279},"University of Toronto - Hospital for Sick Kids","M5G 1E8",{"type":64,"coordinates":277},[267,268],{"lat":268,"lon":267},[280],{"name":281,"role":44,"phone":40,"phoneExt":40,"email":40},"Chia Wei Teoh, MB B.Ch., BAO, LRCSI, MRCPI",{"facility":283,"status":57,"city":263,"state":251,"zip":284,"country":196,"countryCode":197,"cosmosGeoPoint":285,"geoPoint":287,"contacts":288},"University of Toronto","M5S 1A1",{"type":64,"coordinates":286},[267,268],{"lat":268,"lon":267},[289],{"name":290,"role":44,"phone":40,"phoneExt":40,"email":40},"Joseph Kim, MD, PhD",{"facility":292,"status":57,"city":293,"state":294,"zip":295,"country":196,"countryCode":197,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"McGill University","Montreal","Quebec","H3A 0G4",{"type":64,"coordinates":297},[298,299],-73.58781,45.50884,{"lat":299,"lon":298},[302],{"name":303,"role":44,"phone":40,"phoneExt":40,"email":40},"Shaifali Sandal, MD",{"facility":305,"status":57,"city":293,"state":294,"zip":306,"country":196,"countryCode":197,"cosmosGeoPoint":307,"geoPoint":309,"contacts":310},"University of Montreal","H3T 1J4",{"type":64,"coordinates":308},[298,299],{"lat":299,"lon":298},[311],{"name":312,"role":44,"phone":40,"phoneExt":40,"email":40},"Daniel Fantus, MD, FRCPC",{"facility":314,"status":57,"city":315,"state":294,"zip":316,"country":196,"countryCode":197,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"University of Laval","Québec","G1V 0B4",{"type":64,"coordinates":318},[319,320],-71.21454,46.81228,{"lat":320,"lon":319},[323],{"name":324,"role":44,"phone":40,"phoneExt":40,"email":40},"Sacha De Serres, MD, FRCPC",{"facility":326,"status":57,"city":327,"state":328,"zip":329,"country":196,"countryCode":197,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"University of Saskatchewan","Saskatoon","Saskatchewan","S7N 5A2",{"type":64,"coordinates":331},[332,333],-106.66892,52.13238,{"lat":333,"lon":332},[336],{"name":337,"role":44,"phone":40,"phoneExt":40,"email":40},"Rahul Manira, MD, FRCPC",{"facility":339,"status":57,"city":340,"state":341,"zip":342,"country":343,"countryCode":344,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Auckland City Hospital","Grafton","Auckland","1023","New Zealand","NZ",{"type":64,"coordinates":346},[347,348],174.76566,-36.86029,{"lat":348,"lon":347},[351],{"name":352,"role":44,"phone":40,"phoneExt":40,"email":40},"Helen Pilmore",{"type":354,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[356],{"name":47,"class":6},"100552529","phase-3-tackle-it-trial---treat-acute-t-cell-rejection-with-evidence-and-confidence-in-kidney-transplant-recipients-100552529",false,"NCT06474273","TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients","A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients","Inclusion Criteria:\n\n* Participants or their legal guardian must be able to understand and provide written informed consent;\n* Stated willingness to comply with all study procedures and availability for the duration of the study;\n* All ethnic and gender groups will have equal access to the study;\n* All children (aged 2+ years) and adults who have received a kidney or SPK transplant with biopsy proven acute TCMR (≥ Banff borderline (minimum i1 score) whether clinical or subclinical).\n\nExclusion Criteria:\n\n* Mixed rejection.\n* Active or chronic active ABMR.\n* Chronic active TCMR. \\*Patients with concomitant acute TCMR and chronic active TCMR will not be excluded from the trial.\n* Isolated v1 without inflammation.\n* Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus nephropathy.\n* Active malignancies or active infection that preclude immunosuppression augmentation.\n* Use of other immunomodulatory agents, including, but not limited to, Rituximab, Anti-TNF monoclonal antibody, Belatacept, Abatacept, Janus kinase inhibitors, Eculizumab, Pegcetacoplan.\n* Enrolment in other interventional drug trials.\n* Use of other investigational agents.\n* Unable to adhere to the study protocol.","ALL","2 Years",{"count":367,"type":368},540,"ESTIMATED","INTERVENTIONAL",[371],"PHASE3","After a kidney or a simultaneous kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection. One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working.\n\nDoctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That is why we need to find the right dose of steroids for each person to treat this.\n\nTACKLE-IT is a study that will try to find the right steroid dose for treating rejection.",[374,375],"Rejection; Transplant, Kidney","Rejection; Transplant, Pancreas",[377],"Acute T cell mediated rejection","2026-05-04",{"date":380,"type":381},"2026-05-06","ACTUAL",{"date":383,"type":381},"2026-03-13",{"date":385,"type":368},"2030-06",{"name":5,"class":6},25]