[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Geoff Block\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"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":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Anemia Associated With Chronic Kidney Disease","NOT_YET_RECRUITING","2026-04-27",{"date":30,"type":31},"2026-05-04","ACTUAL",{"date":33,"type":20},"2026-04",{"date":35,"type":20},"2027-06",{"name":37,"class":38},"Geoff Block","NETWORK",""]