[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630956":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":11,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Kind Pharmaceuticals LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AND017","EXPERIMENTAL",null,[13],"Drug: AND017 capsules",{"label":15,"type":16,"description":11,"interventionNames":17},"Erythropoiesis Stimulating Agents 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Ding","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100630956","phase-3-a-study-of-and017-to-evaluate-efficacy-and-safety-in-dialysis-dependent-chronic-kidney-disease-dd-ckd-patients-with-anemia-100630956",false,"NCT07494409","A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia","A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia","Key Inclusion Criteria:\n\n* Receiving stable hemodialysis (including combination methods such as hemodiafiltration or hemofiltration), peritoneal dialysis for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription.\n* Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks\n* The mean of two hemoglobin values during screening must be 9.0-12.0 g\u002FdL.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\\\u003C3× upper limit of normal (ULN)\n* Transferrin saturation ≥20% or ferritin ≥100 ng\u002FmL at screening test\n* Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test\n\nKey Exclusion Criteria:\n\n* Concurrent retinal neovascular lesions requiring treatment\n* Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms\n* History of gastric\u002Fintestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment\n* Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure \\>180 mmHg, or diastolic blood pressure \\>110 mmHg during the screening assessment\n* Concurrent congestive heart failure (New York Heart Association \\[NYHA\\] Class III or higher)\n* History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment\n* Participants with a history of significant liver disease or active liver disease\n* History of a seizure disorder or any occurrence of seizures in the past\n* Serum albumin (ALB) \\\u003C 2.5 g\u002FdL at screening test\n* Prior ESA\u002Fhypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment caused total bilirubin \\>1.5xULN, or AST\u002FALT\u002F ALP\\>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.)\n* Any prior functioning organ transplant or a scheduled organ transplantation, or anephric","ALL","18 Years","75 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