[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543151":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":31,"studyPopulation":20,"armGroups":32,"interventions":45,"overallOfficials":59,"centralContacts":64,"locations":73,"responsibleParty":90,"collaborators":20,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":20,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":20,"overallStatus":112,"whyStopped":20,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Megalabs","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Mean Absolute Change in Hemoglobin Levels","Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements.\n\nHemoglobin is the primary endpoint of the study .","18 months",{"measure":14,"description":15,"timeFrame":12},"Change in Mean Hb Level","Response to epoetin alfa in patients with chronic kidney failure is an increase in hematocrit, hemoglobin and reduced transfusion requirements.\n\nHemoglobin is the primary endpoint of the study.",[17],{"measure":18,"description":19,"timeFrame":12},"immunogenicity","Anti-drug antibodies will be assessed in both groups every two weeks.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","multicentre, double-blind, randomised, parallel, equivalence trial","TREATMENT",{"masking":27,"maskingDescription":20,"whoMasked":28},"DOUBLE",[29,30],"PARTICIPANT","CARE_PROVIDER","Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Epoetin alfa Megalabs® injectable in intravenous application.","EXPERIMENTAL","Epoetin alfa Megalabs, Human recombinant epoetin alfa",[38],"Biological: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.",{"label":40,"type":41,"description":42,"interventionNames":43},"Epoetin alfa Epogen® injectable in intravenous application.","ACTIVE_COMPARATOR","USA licenced Epoetin alfa, Epogen®, Human recombinant epoetin alfa",[44],"Biological: Active comparator: European Union licenced epoetin alfa",[46,53],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"BIOLOGICAL","Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration.","comparison vs the reference product to demonstrate biological similarity",[34],[52],"Epoetin alfa Megalabs®, Human recombinant epoetin alfa",{"type":47,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Active comparator: European Union licenced epoetin alfa","comparison vs. the test product to demonstrate biological similarity",[40],[58],"Epogen®, Human recombinant epoetin alfa",[60],{"name":61,"affiliation":62,"role":63},"Satish Kumar, MD","Azidus Principal Investigator","STUDY_DIRECTOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":20,"email":69},"Marcos Giusti, MD","CONTACT","59826838000","mgiusti@megalabs.global",{"name":71,"role":67,"phone":68,"phoneExt":20,"email":72},"Victoria Rodriguez, MD","vrodriguez@megalabs.global",[74],{"facility":5,"status":20,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Colonia Nicolich","Departamento de Canelones","15000","Uruguay","UY",{"type":81,"coordinates":82},"Point",[83,84],-56.02435,-34.81516,{"lat":84,"lon":83},[87],{"name":71,"role":67,"phone":88,"phoneExt":89,"email":72},"26836300","3110",{"type":91,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"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":104,"type":105},280,"ESTIMATED","INTERVENTIONAL",[108],"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",[111],"Anemia of Chronic Kidney Disease","NOT_YET_RECRUITING","2024-08-15",{"date":115,"type":116},"2024-08-19","ACTUAL",{"date":118,"type":105},"2025-07",{"date":120,"type":105},"2027-03",{"name":5,"class":6},1]