[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552529":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":94,"studyPopulation":85,"armGroups":95,"interventions":116,"overallOfficials":128,"centralContacts":135,"locations":141,"responsibleParty":440,"collaborators":442,"id":444,"slug":85,"hasResults":445,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":85,"eligibilityCriteria":449,"healthyVolunteers":445,"sex":450,"minAge":451,"maxAge":85,"enrollmentInfo":452,"targetDuration":85,"studyType":455,"phases":456,"briefSummary":458,"conditions":459,"keywords":462,"overallStatus":185,"whyStopped":85,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":473},{"fullName":5,"class":6},"University of Sydney","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":55},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Histological resolution of biopsy-proven acute rejection","Histological resolution of biopsy-proven acute rejection is defined by the absence of any biopsy-proven acute rejection (BPAR) on follow-up biopsy, including \\\u003CBanff Borderline (i1 t1), mixed rejection, ABMR and chronic active TCMR using Banff 2022 criteria.","12 weeks post-randomization",{"measure":14,"description":15,"timeFrame":12},"Improvement in allograft function","Baseline serum creatinine is defined by an average of three serum creatinine measures: i) first serum creatinine preceding randomisation , ii) serum creatinine at the time of randomisation, iii) serum creatinine at the time of the first IV MP.\n\nReduction in serum creatinine ≥20% is defined as the relative reduction in serum creatinine from baseline and at 12 weeks after randomisation.",{"measure":17,"description":18,"timeFrame":12},"Avoidance of rescue therapies within 12 weeks post-randomization to achieve histological resolution and\u002For improvement in allograft function","Use of rescue therapy is defined as: the use of any adjunctive T and B cell depleting therapies such as intravenous thymoglobulin, alemtuzumab, bortezomib, or rituximab, or additional doses of IV MP within the first 12 weeks after randomization.",[20,24,28,31,35,39,43,47,51],{"measure":21,"description":22,"timeFrame":23},"Estimated glomerular filtration rate (eGFR)","* Absolute eGFR (2021 CKD-EPI eGFR without race modifier for adults, and the CKiD U25 equation to estimate GFR in children \\< 18 years) 12, 24 and 48 weeks.\n* Decline in eGFR (slope) from randomization to 48 weeks.","At 12, 24 and 48 weeks post-randomization",{"measure":25,"description":26,"timeFrame":27},"All cause death and death-censored graft loss","All cause death and death-censored graft loss have been identified as the core outcomes for kidney transplant recipients. However, death and death-censored graft loss are anticipated to have a very low incidence at the 12 weeks post-randomization primary outcome ascertainment and were therefore not included in the primary composite outcome. They will be reported as principal secondary endpoints.","At 12 weeks post-randomization",{"measure":29,"description":30,"timeFrame":23},"Urine albumin: creatinine ratios","Urine ACR is measured as standard of care. Rationale: ACR screens for graft dysfunction and is a marker for graft outcomes",{"measure":32,"description":33,"timeFrame":34},"Quality of life (QoL)","QoL will be assessed using the EuroQol-5 Dimension-5 Level (EQ-5D-5L) for adult participants (aged ≥18 years). For paediatric participants (aged 2-17 years), age-appropriate versions of the EuroQol Youth version (EQ-5D-Y) will be used as follows:\n\n* Ages 4-7: EQ-5D-Y proxy version\n* Ages 8-11: EQ-5D-Y self-report version\n* Ages 12-15: EQ-5D-Y self-report version\n* Age ≥16: EQ-5D-5L adult version\n\nBoth the EQ-5D-5L and EQ-5D-Y report utility scores ranging from -0.281 to 1 (EQ-5D-5L UK value set) and -0.109 to 1 (EQ-5D-Y, proxy or self-report), where 1 represents perfect health, 0 represents a health state equivalent to death, and negative scores represent health states worse than death. Higher scores indicate better health-related quality of life.","Baseline (at randomization), 12 weeks , 24 weeks , and 48 weeks post-randomization",{"measure":36,"description":37,"timeFrame":38},"Cancer","All types and sites","Anytime from randomization to 48 weeks",{"measure":40,"description":41,"timeFrame":42},"Trajectories of serum creatinine changes","An average of three serum creatinine measures will be considered as baseline serum creatinine measures: i) first serum creatinine preceding randomization, ii) serum creatinine at the time of randomisation, iii) serum creatinine at the time of the first IV MP.","From randomization to 48 weeks post-randomization",{"measure":44,"description":45,"timeFrame":46},"Development of acute antibody mediated rejection (ABMR) and mixed rejection (concomitant ABMR + TCMR)","ABMR and mixed rejection are defined according to the Banff 2022 criteria","48 weeks post-randomization",{"measure":48,"description":49,"timeFrame":50},"Infections (including those requiring antimicrobials and hospitalisation)","All types and number of events related to infections that required antimicrobials and hospitalisation for infections will be recorded.","Anytime from randomization to 48 weeks post-randomization",{"measure":52,"description":53,"timeFrame":54},"Development of chronic fibrosis in the allograft","This is defined as a change in ci and ct scores (a marker of interstitial fibrosis and tubular atrophy, measurement of fibrosis, defined by the Banff 2022 criteria)","Baseline to 12 weeks post-randomization",[56,60,64,68,72,76],{"measure":57,"description":58,"timeFrame":59},"Steroid-related adverse effects","Adaption from the Steroid Patient Reported Outcome (Steroid PRO).","3 days post randomisation, 7 days post randomisation, week 12 post-randomisation, week 24 post-randomisation and week 48 post-randomisation",{"measure":61,"description":62,"timeFrame":63},"Integrative Box Risk Prediction Score (iBOX)","Graft survival prediction will be assessed using the Integrative Box Risk Prediction Score (iBOX), a validated composite risk prediction tool for kidney transplant outcomes. The iBOX score integrates clinical, functional, and immunological parameters including serum creatinine, proteinuria, biopsy findings, and presence of donor-specific antibodies to estimate the risk of allograft failure. The iBox score essentially assigns a numerical value based on these parameters, indicating the risk of allograft loss (kidney transplant failure).","Week 13 to week 48 post-randomisation",{"measure":65,"description":66,"timeFrame":67},"Economic evaluation: Incremental costs and benefits","Economic evaluation to compare the incremental benefits (in QALYs) and costs between the treatment arms.","During the 52-week follow up period",{"measure":69,"description":70,"timeFrame":71},"Process evaluation: patients' and clinicians' perspectives on the treatment of acute TCMR","Semi-structured interviews will be conducted to elicit patients' perspectives and experiences of having acute TCMR, the adverse effects of the treatments. Health professionals' will also be interviewed to elicit their perspectives and experiences regarding the barriers, challenges, and enablers for implementing the intervention, the perceived benefits, and harms of the intervention and how the intervention should be delivered such that maximal interactions of the intervention are reached for the intended participants.","Anytime between week 12 and 48 of the trial",{"measure":73,"description":74,"timeFrame":75},"T cell receptor repertoire","To characterise and compare the T cell receptor (TCR) repertoire in transplant recipients who were responsive and not responsive to the various corticosteroid dosing strategies in acute TCMR.","Week 13 to week 48 post-randomization",{"measure":77,"description":78,"timeFrame":79},"Life participation","Life participation will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS®) Ability to Participate in Social Roles and Activities - Short Form 4a (SF4a). This instrument measures perceived ability to perform usual social roles and activities.\n\nScores are reported as T-scores standardized to the general U.S. population (mean = 50, SD = 10).\n\n* Minimum score: 20\n* Maximum score: 80\n\nHigher scores indicate better ability to participate in social roles and activities (i.e., a more favorable outcome).","Randomisation, week 12 post-randomization, week 24 post-randomization and week 48 post-randomization",{"allocation":81,"interventionModel":82,"interventionModelDescription":83,"primaryPurpose":84,"observationalModel":85,"timePerspective":85,"maskingInfo":86},"RANDOMIZED","FACTORIAL","2x2 factorial, triple-blind, non-inferiority, RCT of lower vs higher dose IV MP (methylprednisolone), and lower vs higher oral prednisone dose augmentation.","TREATMENT",null,{"masking":87,"maskingDescription":88,"whoMasked":89},"QUADRUPLE","As a triple-blind study, all investigators, research staff, clinicians, outcome assessors, data analysts and participants will be blinded to the allocation of the IV MP treatment comparisons.\n\nAll key stakeholders including the global steering committee, the site investigators, and the trial management committee (TMC) will remain blinded to the individual patient randomization and the aggregate data that may reveal the unblinded outcomes. All researchers responsible for the analysis will remain blinded for the duration of the trial. Only the members of the Data Safety Monitoring Board (DSMB) and the independent statistician supporting their work will be unblinded prior to study completion.",[90,91,92,93],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","TACKLE-IT is an international, multi-centre, 2x2 factorial, triple-blind, non-inferiority registry-embedded, randomised controlled trial (RCT) that compares the effectiveness and safety of high vs low dose IV MP, and high vs low dose oral prednisone taper as the first-line therapy for acute TCMR in kidney and SPK transplant recipients. This RCT was conceived and developed through extensive consultation and collaboration with our key stakeholders, including transplant recipients with lived experience and the International TCMR Working Group with sponsorship by 4 international transplant societies (The Transplantation Society (TTS), American Society of Transplantation (AST), European Society of Transplantation (ESOT) and Transplant Society of Australia and New Zealand (TSANZ). TACKLE-IT is led by an international multi-disciplinary team of transplant health professionals, clinical trialists, biostatisticians, health economist, social scientist, consumers.\n\nTACKLE-IT will address the critical unmet need and resolve a decades-long unanswered question, 'What is the minimally acceptable, safe and effective steroid dose for the treatment of acute TCMR in kidney and SPK transplant recipients?'",[96,103,107,112],{"label":97,"type":98,"description":99,"interventionNames":100},"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.",[101,102],"Drug: Methylprednisolone","Drug: Prednisone",{"label":104,"type":98,"description":105,"interventionNames":106},"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.",[101,102],{"label":108,"type":109,"description":110,"interventionNames":111},"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.",[101,102],{"label":113,"type":109,"description":114,"interventionNames":115},"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.",[101,102],[117,124],{"type":118,"name":119,"description":120,"armGroupLabels":121,"otherNames":122},"DRUG","Methylprednisolone","IV Methylprednisolone",[113,108,104,97],[123],"IV MP",{"type":118,"name":125,"description":126,"armGroupLabels":127,"otherNames":85},"Prednisone","Oral prednisone augmentation",[113,108,104,97],[129,132],{"name":130,"affiliation":5,"role":131},"Germaine Wong, PhD, FRACP","PRINCIPAL_INVESTIGATOR",{"name":133,"affiliation":134,"role":131},"Julie Ho, FRCPC","University of Manitoba",[136],{"name":137,"role":138,"phone":139,"phoneExt":85,"email":140},"NHMRC Clinical Trials Centre THE UNIVERSITY OF SYDNEY","CONTACT","+61 2 9562 5000","tackle-it.study@sydney.edu.au",[142,159,171,183,192,205,217,230,245,258,266,278,293,302,314,322,335,348,360,369,378,391,400,412,425],{"facility":143,"status":144,"city":145,"state":146,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":155,"contacts":156},"John Hunter Hospital","NOT_YET_RECRUITING","Lambton","New South Wales","2305","Australia","AU",{"type":151,"coordinates":152},"Point",[153,154],151.7,-32.91667,{"lat":154,"lon":153},[157],{"name":158,"role":131,"phone":85,"phoneExt":85,"email":85},"Thida Myint, FRACP",{"facility":160,"status":144,"city":161,"state":146,"zip":162,"country":148,"countryCode":149,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Prince of Wales Hospital","Randwick","2031",{"type":151,"coordinates":164},[165,166],151.24895,-33.91439,{"lat":166,"lon":165},[169],{"name":170,"role":131,"phone":85,"phoneExt":85,"email":85},"Kenneth Yong, FRACP, PhD",{"facility":172,"status":144,"city":173,"state":146,"zip":174,"country":148,"countryCode":149,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"The Sydney Children's Hospital Network","Westmead","2145",{"type":151,"coordinates":176},[177,178],150.98768,-33.80383,{"lat":178,"lon":177},[181],{"name":182,"role":131,"phone":85,"phoneExt":85,"email":85},"Siah Kim, FRACP, PhD",{"facility":184,"status":185,"city":173,"state":146,"zip":174,"country":148,"countryCode":149,"cosmosGeoPoint":186,"geoPoint":188,"contacts":189},"Westmead Hospital","RECRUITING",{"type":151,"coordinates":187},[177,178],{"lat":178,"lon":177},[190],{"name":191,"role":131,"phone":85,"phoneExt":85,"email":85},"Germaine Wong, FRACP, Phd",{"facility":193,"status":185,"city":194,"state":195,"zip":196,"country":148,"countryCode":149,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Queensland Children's Hospital","South Brisbane","Queensland","2014",{"type":151,"coordinates":198},[199,200],153.02049,-27.48034,{"lat":200,"lon":199},[203],{"name":204,"role":131,"phone":85,"phoneExt":85,"email":85},"Anna Francis, PhD, FRACP",{"facility":206,"status":144,"city":207,"state":195,"zip":208,"country":148,"countryCode":149,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Princess Alexandra Hospital","Woolloongabba","4102",{"type":151,"coordinates":210},[211,212],153.03655,-27.48855,{"lat":212,"lon":211},[215],{"name":216,"role":131,"phone":85,"phoneExt":85,"email":85},"Carmel Hawley, FRACP, MMSc",{"facility":218,"status":144,"city":219,"state":220,"zip":221,"country":148,"countryCode":149,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":151,"coordinates":223},[224,225],138.59863,-34.92866,{"lat":225,"lon":224},[228],{"name":229,"role":131,"phone":85,"phoneExt":85,"email":85},"Michael Collins, FRACP, PhD",{"facility":231,"status":144,"city":232,"state":233,"zip":234,"country":148,"countryCode":149,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Monash Medical Centre","Clayton","Victoria","3168",{"type":151,"coordinates":236},[237,238],145.11667,-37.91667,{"lat":238,"lon":237},[241,243],{"name":242,"role":131,"phone":85,"phoneExt":85,"email":85},"John Kanellis, FRACP, PhD",{"name":244,"role":131,"phone":85,"phoneExt":85,"email":85},"William Mulley, FRACP, PhD",{"facility":246,"status":144,"city":247,"state":248,"zip":249,"country":148,"countryCode":149,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"Royal Perth Children's hospital","Nedlands","Western Australia","6009",{"type":151,"coordinates":251},[252,253],115.8073,-31.98184,{"lat":253,"lon":252},[256],{"name":257,"role":131,"phone":85,"phoneExt":85,"email":85},"Nick Larkins, FRACP, PhD",{"facility":259,"status":144,"city":247,"state":248,"zip":249,"country":148,"countryCode":149,"cosmosGeoPoint":260,"geoPoint":262,"contacts":263},"Sir Charles Gairdner Hospital",{"type":151,"coordinates":261},[252,253],{"lat":253,"lon":252},[264],{"name":265,"role":131,"phone":85,"phoneExt":85,"email":85},"Wai Lim, FRACP, PHD",{"facility":267,"status":144,"city":268,"state":248,"zip":269,"country":148,"countryCode":149,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"Royal Perth Hospital","Perth","6000",{"type":151,"coordinates":271},[272,273],115.8614,-31.95224,{"lat":273,"lon":272},[276],{"name":277,"role":131,"phone":85,"phoneExt":85,"email":85},"Mark Thomas, FRACP",{"facility":279,"status":144,"city":280,"state":281,"zip":282,"country":283,"countryCode":284,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"University of Calgary","Calgary","Alberta","T2N 1N4","Canada","CA",{"type":151,"coordinates":286},[287,288],-114.08529,51.05011,{"lat":288,"lon":287},[291],{"name":292,"role":131,"phone":85,"phoneExt":85,"email":85},"Ngan Lam, MD, MSc",{"facility":294,"status":144,"city":295,"state":281,"zip":296,"country":283,"countryCode":284,"cosmosGeoPoint":297,"geoPoint":301,"contacts":85},"University of Alberta","Edmonton","T6G 2R3",{"type":151,"coordinates":298},[299,300],-113.46871,53.55014,{"lat":300,"lon":299},{"facility":303,"status":144,"city":304,"state":305,"zip":306,"country":283,"countryCode":284,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"Transplant Manitoba, adult","Winnipeg","Manitoba","R3A 1R9",{"type":151,"coordinates":308},[309,310],-97.14704,49.8844,{"lat":310,"lon":309},[313],{"name":133,"role":131,"phone":85,"phoneExt":85,"email":85},{"facility":315,"status":144,"city":304,"state":305,"zip":306,"country":283,"countryCode":284,"cosmosGeoPoint":316,"geoPoint":318,"contacts":319},"Transplant Manitoba, pediatric",{"type":151,"coordinates":317},[309,310],{"lat":310,"lon":309},[320],{"name":321,"role":131,"phone":85,"phoneExt":85,"email":85},"Aviva Goldberg, MD",{"facility":323,"status":144,"city":324,"state":325,"zip":326,"country":283,"countryCode":284,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Dalhousie University","Halifax","Nova Scotia","B3H 4R2",{"type":151,"coordinates":328},[329,330],-63.57688,44.64269,{"lat":330,"lon":329},[333],{"name":334,"role":131,"phone":85,"phoneExt":85,"email":85},"Amanda Vinson, MD",{"facility":336,"status":144,"city":337,"state":338,"zip":339,"country":283,"countryCode":284,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"Western University","London","Ontario","N6A 3K7",{"type":151,"coordinates":341},[342,343],-81.23304,42.98339,{"lat":343,"lon":342},[346],{"name":347,"role":131,"phone":85,"phoneExt":85,"email":85},"Matthew Weir, MD, FRCPC",{"facility":349,"status":144,"city":350,"state":338,"zip":351,"country":283,"countryCode":284,"cosmosGeoPoint":352,"geoPoint":356,"contacts":357},"University of Toronto - St Michael Hospital","Toronto","M5B 1W8",{"type":151,"coordinates":353},[354,355],-79.39864,43.70643,{"lat":355,"lon":354},[358],{"name":359,"role":131,"phone":85,"phoneExt":85,"email":85},"Darren Yuen, MD, PhD",{"facility":361,"status":144,"city":350,"state":338,"zip":362,"country":283,"countryCode":284,"cosmosGeoPoint":363,"geoPoint":365,"contacts":366},"University of Toronto - Hospital for Sick Kids","M5G 1E8",{"type":151,"coordinates":364},[354,355],{"lat":355,"lon":354},[367],{"name":368,"role":131,"phone":85,"phoneExt":85,"email":85},"Chia Wei Teoh, MB B.Ch., BAO, LRCSI, MRCPI",{"facility":370,"status":144,"city":350,"state":338,"zip":371,"country":283,"countryCode":284,"cosmosGeoPoint":372,"geoPoint":374,"contacts":375},"University of Toronto","M5S 1A1",{"type":151,"coordinates":373},[354,355],{"lat":355,"lon":354},[376],{"name":377,"role":131,"phone":85,"phoneExt":85,"email":85},"Joseph Kim, MD, PhD",{"facility":379,"status":144,"city":380,"state":381,"zip":382,"country":283,"countryCode":284,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"McGill University","Montreal","Quebec","H3A 0G4",{"type":151,"coordinates":384},[385,386],-73.58781,45.50884,{"lat":386,"lon":385},[389],{"name":390,"role":131,"phone":85,"phoneExt":85,"email":85},"Shaifali Sandal, MD",{"facility":392,"status":144,"city":380,"state":381,"zip":393,"country":283,"countryCode":284,"cosmosGeoPoint":394,"geoPoint":396,"contacts":397},"University of Montreal","H3T 1J4",{"type":151,"coordinates":395},[385,386],{"lat":386,"lon":385},[398],{"name":399,"role":131,"phone":85,"phoneExt":85,"email":85},"Daniel Fantus, MD, FRCPC",{"facility":401,"status":144,"city":402,"state":381,"zip":403,"country":283,"countryCode":284,"cosmosGeoPoint":404,"geoPoint":408,"contacts":409},"University of Laval","Québec","G1V 0B4",{"type":151,"coordinates":405},[406,407],-71.21454,46.81228,{"lat":407,"lon":406},[410],{"name":411,"role":131,"phone":85,"phoneExt":85,"email":85},"Sacha De Serres, MD, FRCPC",{"facility":413,"status":144,"city":414,"state":415,"zip":416,"country":283,"countryCode":284,"cosmosGeoPoint":417,"geoPoint":421,"contacts":422},"University of Saskatchewan","Saskatoon","Saskatchewan","S7N 5A2",{"type":151,"coordinates":418},[419,420],-106.66892,52.13238,{"lat":420,"lon":419},[423],{"name":424,"role":131,"phone":85,"phoneExt":85,"email":85},"Rahul Manira, MD, FRCPC",{"facility":426,"status":144,"city":427,"state":428,"zip":429,"country":430,"countryCode":431,"cosmosGeoPoint":432,"geoPoint":436,"contacts":437},"Auckland City Hospital","Grafton","Auckland","1023","New Zealand","NZ",{"type":151,"coordinates":433},[434,435],174.76566,-36.86029,{"lat":435,"lon":434},[438],{"name":439,"role":131,"phone":85,"phoneExt":85,"email":85},"Helen Pilmore",{"type":441,"investigatorFullName":85,"investigatorTitle":85,"investigatorAffiliation":85,"oldNameTitle":85,"oldOrganization":85},"SPONSOR",[443],{"name":134,"class":6},"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":453,"type":454},540,"ESTIMATED","INTERVENTIONAL",[457],"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.",[460,461],"Rejection; Transplant, Kidney","Rejection; Transplant, Pancreas",[463],"Acute T cell mediated rejection","2026-05-04",{"date":466,"type":467},"2026-05-06","ACTUAL",{"date":469,"type":467},"2026-03-13",{"date":471,"type":454},"2030-06",{"name":5,"class":6},25]