[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100073533":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":10,"locations":10,"responsibleParty":23,"collaborators":10,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":30,"acronym":10,"eligibilityCriteria":31,"healthyVolunteers":27,"sex":32,"minAge":33,"maxAge":10,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":10,"briefSummary":38,"conditions":39,"keywords":42,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":10},{"fullName":5,"class":6},"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants Receiving Epoetin Alfa or Another Erythropoietin",null,"Participants will not receive any intervention in this study. Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins will be prospectively observed to monitor incidence of pure red cell aplasia and\u002For antibodies to erythropoietin. Participants will receive standard-of-care treatment for their chronic renal (or other) disease from their individual Investigators.",[13],"Other: No Intervention",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":10},"OTHER","No Intervention",[9],[20],{"name":21,"affiliation":5,"role":22},"Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial","STUDY_DIRECTOR",{"type":24,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100073533","study-to-monitor-the-incidence-of-pure-red-cell-aplasia-prca-andor-antibodies-to-erythropoietin-among-participants-receiving-epoetin-alfa-or-another-erythropoietin-100073533",false,"NCT00210951","Study to Monitor the Incidence of Pure Red Cell Aplasia (PRCA) and\u002For Antibodies to Erythropoietin Among Participants Receiving Epoetin Alfa or Another Erythropoietin","An Active Safety Surveillance Plan to Conduct Serologic Testing for Anti-erythropoietin Antibodies and Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa or Another Erythropoietin","Inclusion Criteria:\n\n* Male or female participants of legal age to give consent according to local standards\n* Participants must be receiving or about to receive treatment with an erythropoietin as part of a pre-existing treatment plan for their chronic renal (or other) disease\n* Physicians treating the participants must agree in advance to document any appearance of pure red cell aplasia (PRCA) such that information and details of the case may be reported to regulatory agencies (with patient identification protected)\n* If required by local ethics committees, participants must give consent to permit the collection of de-identified personal data for the specific purpose of this study and to collect blood samples for tests for antibodies to erythropoietin\n\nExclusion Criteria:\n\n* Participants who are unable to complete future follow-up visits\n* Participants who when entering the study have any of the following symptoms of pure red cell aplasia (PRCA): Loss of effectiveness of erythropoietin or low number of immature red blood cells while on erythropoietin as shown by a blood test or bone marrow examination\n* Participants with a history of PRCA or loss of effectiveness with erythropoietin at the time of enrollment into the study\n* Participants whose anemia did not respond to previous treatment with an erythropoietin\n* Participants with a history of antibodies to erythropoietin prior to entering the study","ALL","18 Years",{"count":35,"type":36},4761,"ACTUAL","OBSERVATIONAL","The purpose of this study is to assess the incidence of pure red cell aplasia (PRCA \\[suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production\\]) among participants with chronic renal failure (CRF), who were receiving treatment with epoetin alfa or other exogenous recombinant erythropoietin therapies.",[40,41],"Red-Cell Aplasia, Pure","Chronic Renal Failure",[43,44,45,41],"Epoetin alfa","Erythropoietin","Red Cell Aplasia, Pure","COMPLETED","2015-03-23",{"date":49,"type":50},"2015-03-24","ESTIMATED",{"date":52,"type":10},"2003-05",{"date":54,"type":36},"2005-07",{"name":5,"class":6}]