[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636439":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":28,"collaborators":32,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":11,"enrollmentInfo":45,"targetDuration":11,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":11},{"fullName":5,"class":6},"USRC Kidney Research","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phased transition from Epogen to three times weekly (TIW) oral vadadustat","EXPERIMENTAL",null,[13],"Drug: Epoetin alga (Epogen)\u002Fvadadustat",[15],{"type":16,"name":17,"description":9,"armGroupLabels":18,"otherNames":11},"DRUG","Epoetin alga (Epogen)\u002Fvadadustat",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Stephanie Brillhart","CONTACT","13038819451","stephanie.brillhart@usrenalcare.com",{"name":26,"role":22,"phone":11,"phoneExt":11,"email":27},"Martha Block","martha.block@usrenalcare.com",{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Geoff Block","Senior Vice President of Research and Associate Chief Medical Officer",[33],{"name":34,"class":35},"Akebia Therapeutics","INDUSTRY","100636439","phase-3-safety-and-efficacy-of-a-phased-transition-from-epogen-to-three-times-weekly-oral-vadadustat-for-the-treatment-of-anemia-in-subjects-receiving-in-center-hemodialysis-100636439",false,"NCT07565701","Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis","VOTE","Inclusion Criteria:\n\n* Adult patients ≥18 years of age\n* Receiving outpatient in-center hemodialysis for ESKD at least TIW (prescribed)\n* Currently receiving EPO (active administration, not on HOLD)\n* Less than or equal to 0.75 g\u002Fd difference between last 2 Hgb values prior to Screening, with neither Hgb \\\u003C9 g\u002FdL\n* Average of last 2 Hgb between 9-11.4 g\u002FdL (inclusive) prior to Screening\n* Central Screening Hgb 9-11.4 g\u002FdL (inclusive)\n* Central Screening transferrin saturation greater than or equal to 20%\n* Central Screening serum ferritin greater than or equal to 100 ng\u002FmL\n* Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure\n\nExclusion Criteria:\n\n* Contraindication to receive vadadustat per United States Prescribing Information (USPI) including Screening liver function tests greater than 3x the upper limit of normal (ULN)\n* Electronic Medical Record (EMR)-documented history of cirrhosis or active, acute liver disease\n* EMR-documented history of currently active malignancy excluding non-melanomatous skin cancer and in-situ cervical cancer\n* Concomitant use of HIF-PHI or OAT1\u002FOAT3 inhibitors (probenecid, rifampicin, gemfibrozil, or teriflunomide)\n* Unable to comply with study requirements or in the opinion of a healthcare provider or member of the central study team, not clinically stable to participate in the study\n* Documented unplanned absence from dialysis greater than or equal to 3 times in 30 days prior to Screening (excluding rescheduled dialysis treatments)\n* Pregnant at time of consent (per subject self-report)","ALL","18 Years",{"count":46,"type":47},100,"ESTIMATED","INTERVENTIONAL",[50],"PHASE3","The goal of this study is to assess if patients can be retained on long-term vadadustat therapy (and thus potentially benefit from the favorable safety profile) by incorporating a phased transition from Epogen to three times per week vadadustat (TIW-V), reducing the likelihood of GI intolerance through use of a lower vadadustat starting dose, and also reducing or eliminating the initial reduction in hemoglobin through the maintenance of low dose Epogen until target hemoglobin stability is achieved on a tolerable dose of TIW-V.",[53],"Anemia Associated With Chronic Kidney Disease","NOT_YET_RECRUITING","2026-04-27",{"date":57,"type":58},"2026-05-04","ACTUAL",{"date":60,"type":47},"2026-04",{"date":62,"type":47},"2027-06",{"name":30,"class":6}]