[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543151":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":66,"collaborators":44,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":44,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":44,"overallStatus":88,"whyStopped":44,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Megalabs","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Epoetin alfa Megalabs® injectable in intravenous application.","EXPERIMENTAL","Epoetin alfa Megalabs, Human recombinant epoetin alfa",[13],"Biological: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.",{"label":15,"type":16,"description":17,"interventionNames":18},"Epoetin alfa Epogen® injectable in intravenous application.","ACTIVE_COMPARATOR","USA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa",[19],"Biological: Active comparator: European Union licenced epoetin alfa",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.","comparison vs the reference product to demonstrate biological similarity",[9],[27],"Epoetin alfa Megalabs®, Human recombinant epoetin alfa",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Active comparator: European Union licenced epoetin alfa","comparison vs. the test product to demonstrate biological similarity",[15],[33],"Epogen®, Human recombinant epoetin alfa",[35],{"name":36,"affiliation":37,"role":38},"Satish Kumar, MD","Azidus Principal Investigator","STUDY_DIRECTOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Marcos Giusti, MD","CONTACT","59826838000",null,"mgiusti@megalabs.global",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":48},"Victoria Rodriguez, MD","vrodriguez@megalabs.global",[50],{"facility":5,"status":44,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Colonia Nicolich","Departamento de Canelones","15000","Uruguay","UY",{"type":57,"coordinates":58},"Point",[59,60],-56.02435,-34.81516,{"lat":60,"lon":59},[63],{"name":47,"role":42,"phone":64,"phoneExt":65,"email":48},"26836300","3110",{"type":67,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100543151","phase-3-comparative-study-of-two-recombinant-human-erythropoietin-products-in-chronic-kidney-disease-patients-100543151",false,"NCT06352138","Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients","Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i\u002Fv Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease","ENCASE","Inclusion Criteria:\n\n* Stage V Chronic kidney disease undergoing hemodialysis\n\nExclusion Criteria:\n\n* Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies","ALL","18 Years","65 Years",{"count":80,"type":81},280,"ESTIMATED","INTERVENTIONAL",[84],"PHASE3","Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis",[87],"Anemia of Chronic Kidney Disease","NOT_YET_RECRUITING","2024-08-15",{"date":91,"type":92},"2024-08-19","ACTUAL",{"date":94,"type":81},"2025-07",{"date":96,"type":81},"2027-03",{"name":5,"class":6},1]