[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100179780":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":43,"locations":44,"responsibleParty":141,"collaborators":43,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":43,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":43,"maxAge":151,"enrollmentInfo":152,"targetDuration":43,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":163,"overallStatus":171,"whyStopped":43,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Astellas Pharma Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tacrolimus","ACTIVE_COMPARATOR","Participants receive tacrolimus twice daily starting from day 1 for 4 weeks for in Part A, and continue to receive tacrolimus twice daily up to end of Part B and C of the study.",[13],"Drug: Tacrolimus",{"label":15,"type":16,"description":17,"interventionNames":18},"Tacrolimus Prolonged Release","EXPERIMENTAL","Participants receive tacrolimus prolonged release once daily starting from day 1 for 4 weeks for in Part A, and continue to receive tacrolimus prolonged release once daily up to end of Part B and of the study.",[19],"Drug: Tacrolimus prolonged release",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants receive an initial total daily dose of tacrolimus depending on the type of organ transplant (heart = 0.075 mg\u002Fkg; liver\u002Fkidney = 0.3 mg\u002Fkg), to be given orally (or via nasogastric tube for liver transplant recipients) in 2 doses in the morning and the evening. The first dose is administered in the morning within days of skin closure (heart = 4 days; liver = 2 days; kidney = within 24 hours following reperfusion). Subsequent tacrolimus doses are taken orally twice a day in the morning and evening and are adjusted on the basis of clinical evidence of efficacy, occurrence of adverse events and observing the recommended whole blood trough level ranges (day 1 through 21 = 10 to 20 ng\u002FmL; day 22 through 365 = 5 to 15 ng\u002FmL).",[9],[26,27],"Prograf","FK506",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Tacrolimus prolonged release","Participants receive an initial total daily dose of tacrolimus prolonged release depending on the type of organ transplant (heart = 0.075 mg\u002Fkg; liver\u002Fkidney = 0.3 mg\u002Fkg), to be given orally (or via nasogastric tube for liver transplant recipients) in 1 dose. The first dose is administered in the morning within days of skin closure (heart = 4 days; liver = 2 days; kidney = within 24 hours following reperfusion). Subsequent tacrolimus prolonged release doses are taken orally once a day in the morning and are adjusted on the basis of clinical evidence of efficacy, occurrence of adverse events and observing the recommended whole blood trough level ranges (day 1 through 21 = 10 to 20 ng\u002FmL; day 22 through 365 = 5 to 15 ng\u002FmL).",[15],[33,34,35,36,37],"Prograf XL","Graceptor","FK506 (MR4)","Advagraf","Astagraf XL",[39],{"name":40,"affiliation":41,"role":42},"Clinical Study Manager","Astellas Pharma Europe Ltd.","STUDY_DIRECTOR",null,[45,56,67,75,86,97,108,117,126,132],{"facility":46,"status":43,"city":47,"state":43,"zip":48,"country":49,"countryCode":43,"cosmosGeoPoint":50,"geoPoint":55,"contacts":43},"Site CZ61","Prague","150 06","Czechia",{"type":51,"coordinates":52},"Point",[53,54],14.42076,50.08804,{"lat":54,"lon":53},{"facility":57,"status":43,"city":58,"state":43,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":43},"Site FR33","Bron","69677","France","FR",{"type":51,"coordinates":63},[64,65],4.91303,45.73865,{"lat":65,"lon":64},{"facility":68,"status":43,"city":69,"state":43,"zip":43,"country":60,"countryCode":61,"cosmosGeoPoint":70,"geoPoint":74,"contacts":43},"Site FR32","Paris",{"type":51,"coordinates":71},[72,73],2.3488,48.85341,{"lat":73,"lon":72},{"facility":76,"status":43,"city":77,"state":43,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":43},"Site IT52","Rome","00165","Italy","IT",{"type":51,"coordinates":82},[83,84],12.51133,41.89193,{"lat":84,"lon":83},{"facility":87,"status":43,"city":88,"state":43,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":43},"Site PL71","Warsaw","04-730","Poland","PL",{"type":51,"coordinates":93},[94,95],21.01178,52.22977,{"lat":95,"lon":94},{"facility":98,"status":43,"city":99,"state":43,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":107,"contacts":43},"Site GB43","Birmingham","B4 6NH","United Kingdom","UK",{"type":51,"coordinates":104},[105,106],-1.89983,52.48142,{"lat":106,"lon":105},{"facility":109,"status":43,"city":110,"state":43,"zip":111,"country":101,"countryCode":102,"cosmosGeoPoint":112,"geoPoint":116,"contacts":43},"Site GB46","Liverpool","L12 2AP",{"type":51,"coordinates":113},[114,115],-2.97794,53.41058,{"lat":115,"lon":114},{"facility":118,"status":43,"city":119,"state":43,"zip":120,"country":101,"countryCode":102,"cosmosGeoPoint":121,"geoPoint":125,"contacts":43},"Site GB44","London","SE5 9RS",{"type":51,"coordinates":122},[123,124],-0.12574,51.50853,{"lat":124,"lon":123},{"facility":127,"status":43,"city":119,"state":43,"zip":128,"country":101,"countryCode":102,"cosmosGeoPoint":129,"geoPoint":131,"contacts":43},"Site GB45","WC1 3JH",{"type":51,"coordinates":130},[123,124],{"lat":124,"lon":123},{"facility":133,"status":43,"city":134,"state":43,"zip":135,"country":101,"countryCode":102,"cosmosGeoPoint":136,"geoPoint":140,"contacts":43},"Site GB42","Manchester","M13 9WL",{"type":51,"coordinates":137},[138,139],-2.23743,53.48095,{"lat":139,"lon":138},{"type":142,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100179780","phase-2-a-study-to-compare-how-the-body-absorbs-and-processes-two-different-formulations-of-the-anti-rejection-medication-tacrolimus-advagraf-or-prograf-in-children-receiving-an-organ-transplant-and-how-safe-and-effective-they-are-over-a-longer-period-of-time-100179780",false,"NCT01614665","A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time","A Phase II, Parallel Group, Randomized, Multicentre, Open Label Study to Compare the Pharmacokinetics of Tacrolimus in De Novo Pediatric Allograft Recipients Treated With an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up","Inclusion Criteria:\n\n* The subject is aged \\\u003C16 years of age, undergoing primary liver, kidney or heart allograft transplantation\n* The subject must be able to swallow intact Prograf® or Advagraf® capsules\n* Subjects, treated since transplantation with Basiliximab or ATG\u002F Mycophenolate Mofetil (MMF)\u002Fsteroids, whose gastric motility has resumed and whose renal function is adequate on Day 1 (Heart only)\n\nExclusion Criteria:\n\n* Subject is receiving a multi-organ transplant or has previously received an organ transplant (including re-transplantation)\n* Subject with pulmonary vascular resistance ≥4 Wood units despite medication\n* Subject with significant renal impairment, defined as having serum creatinine ≥230 μmol\u002Fl (≥2.6 mg\u002Fdl) pre-transplantation. (Not applicable for renal transplanted subjects)\n* Subject with significant liver disease, defined as having continuously elevated SGPT\u002FALT and\u002For SGOT\u002FAST and\u002For total bilirubin levels of ≥3 times the upper value of the normal range of the investigational site during the past 28 days. (Not applicable for liver transplanted subjects)\n* Subject with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully. (Not applicable for transplanted subjects with a primary organ diagnosis of cancer)\n* Subject requiring systemic immunosuppressive medication for any other indication than transplantation","ALL","15 Years",{"count":153,"type":154},44,"ACTUAL","INTERVENTIONAL",[157],"PHASE2","The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and effective they are over a longer period of time.\n\nThis study is for children less than 16 years old. No minimum age has been set, however, to be included in this study participants must able to swallow the medication capsules intact.",[160,161,162],"Heart Transplantation","Kidney Transplantation","Liver Transplantation",[164,26,165,36,9,166,167,168,169,170],"Transplant","Heart","Immunosuppression","Kidney","Liver","Pharmacokinetic","Pediatric","COMPLETED","2024-10-30",{"date":174,"type":154},"2024-11-01",{"date":176,"type":154},"2012-04-03",{"date":178,"type":154},"2021-04-21",{"name":41,"class":6},10]