[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658664":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":38,"armGroups":39,"interventions":33,"overallOfficials":43,"centralContacts":48,"locations":33,"responsibleParty":54,"collaborators":33,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":33,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":33,"enrollmentInfo":67,"targetDuration":33,"studyType":70,"phases":33,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":81,"whyStopped":33,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":87,"leadSponsor":89,"locationsCount":33},{"fullName":5,"class":6},"Assiut University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of new-onset ESA hyporesponsiveness","Proportion of patients who develop new-onset ESA hyporesponsiveness, defined as erythropoietin resistance index (ERI) \\> 15.4 during the 12-month follow-up.","12 months",[14,17,20,24,27,30],{"measure":15,"description":16,"timeFrame":12},"Proportion of patients with persistent ESA hyporesponsiveness","Proportion of patients with ESA hyporesponsiveness (ERI \\> 15.4) persisting for more than 4 months.",{"measure":18,"description":19,"timeFrame":12},"Proportion of patients who recover from ESA hyporesponsiveness","Proportion of patients who recover from ESA hyporesponsiveness (ERI ≤ 15.4) during follow-up.",{"measure":21,"description":22,"timeFrame":23},"Mean erythropoietin resistance index","Mean erythropoietin resistance index (ERI) calculated as weekly ESA dose (IU\u002Fweek) \u002F \\[body weight (kg) × hemoglobin (g\u002FdL)\\].","Baseline and at 12 months",{"measure":25,"description":26,"timeFrame":23},"Mean serum ferritin","Mean serum ferritin level in ng\u002FmL.",{"measure":28,"description":29,"timeFrame":23},"Mean serum albumin","Mean serum albumin level in g\u002FdL.",{"measure":31,"description":32,"timeFrame":23},"Mean C-reactive protein","Mean C-reactive protein (CRP) level in mg\u002FL.",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","Anemia is a common complication in patients receiving maintenance hemodialysis. Response to erythropoiesis-stimulating agents varies, and some patients develop hyporesponsiveness.\n\nThis observational study will include adult patients on maintenance hemodialysis who are receiving ESA therapy. The erythropoietin resistance index (ERI) will be calculated at baseline and during 12 months of follow-up to identify development, persistence, and recovery of ESA hyporesponsiveness.","Adult patients with end-stage renal disease receiving maintenance hemodialysis at the Hemodialysis Center, Assiut University Hospital.",[40],{"label":41,"type":33,"description":42,"interventionNames":33},"Single cohort: Maintenance Hemodialysis Patients","Adult patients receiving maintenance hemodialysis and ESA therapy who will be followed for 12 months to assess development, persistence, and recovery of ESA hyporesponsiveness.",[44],{"name":45,"affiliation":46,"role":47},"Marwa k Abdo, prof","Internal Medicine Department, Assiut University Hospitals","STUDY_CHAIR",[49],{"name":50,"role":51,"phone":52,"phoneExt":33,"email":53},"Hamid I Hamid, Resident","CONTACT","+201122287965","hamidebrheem@gmail.com",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Hamid Ibrahim Hamid","Resident Physician, Department of Internal Medicine","100658664","esa-hyporesponsiveness-in-hemodialysis-patients-100658664",false,"NCT07855458","ESA Hyporesponsiveness in Hemodialysis Patients","Predictors of Development and Persistence of Erythropoietin-Stimulating Agents Hyporesponsiveness in Hemodialysis Patients","Inclusion Criteria:\n\n* Age ≥18 years.\n* ESRD\u002FCKD G5D receiving maintenance hemodialysis.\n* Hemodialysis ≥3 months before enrollment.\n* Receiving ESA therapy for anemia.\n* Expected to remain on hemodialysis during the study period.\n* Baseline Hb and ESA dose available.\n\nExclusion Criteria:\n\n* Active malignancy.\n* Hematological malignancy.\n* Known hemoglobinopathy causing anemia.\n* Recent blood transfusion, e.g. within 3 months before enrollment.\n* Recent major surgery.\n* Active major bleeding.\n* Pregnancy.\n* Recent kidney transplantation.\n* Known pure red-cell aplasia.\n* Incomplete clinical or laboratory follow-up","ALL","18 Years",{"count":68,"type":69},200,"ESTIMATED","OBSERVATIONAL","This prospective cohort study aims to evaluate the development, persistence, and recovery of erythropoiesis-stimulating agent (ESA) hyporesponsiveness among patients receiving maintenance hemodialysis.",[73,74,75],"Chronic Kidney Disease (CKD)","Hemodialysis Complication","Anemia",[77,78,79,75,80],"Hemodialysis","ESA hyporesponsiveness","Erythropoietin resistance index","Assiut","NOT_YET_RECRUITING","2026-09-28",{"date":84,"type":85},"2026-10-02","ACTUAL",{"date":84,"type":69},{"date":88,"type":69},"2028-03-01",{"name":5,"class":6}]