[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anemia-due-to-chronic-kidney-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anemia-due-to-chronic-kidney-disease":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100630442",false,"NCT07487727","A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)","A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) Patients","Key Inclusion Criteria:\n\n* A diagnosis of CKD confirmed at screening, KDOQI CKD stage 3, 4, or 5 defined by estimated Glomerular Filtration Rate (eGFR) using the CKD Epidemiology Collaboration (EPI) formula.\n* Not on dialysis and no clinical evidence of impending need to initiate dialysis during the study treatment.\n* Prior ESA and hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment\n\n  1. ESA\u002FHIF-PHI-naïve: Defined as no use of any ESA\u002FHIF-PHI treatment for at least 12 weeks before randomization; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be ≥7.5 g\u002FdL and \\\u003C10.0 g\u002FdL with a difference of ≤1.3 g\u002FdL between the two values;\n  2. ESA-treated: Defined as having received an approved ESA, administered intravenously or subcutaneously, for at least 6 weeks prior to randomization, with no change in ESA product and no treatment interruption exceeding 2 consecutive weeks; Mean of the two most recent Hb values during the screening period obtained at least 7 days apart must be 9.0-12.0 g\u002FdL inclusive.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3× upper limit of normal (ULN)\n* Transferrin saturation (TSAT) ≥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\u002FHIF-PHI treatment caused total bilirubin \\>1.5xULN, or AST\u002FALT\u002FALP\\>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 Years",{"count":19,"type":20},240,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in non-dialysis-dependent (NDD)-CKD patients compared with the active control, ESA treatment",[26],"Anemia Due to Chronic Kidney Disease",[28,29],"anemia","CKD","RECRUITING","2026-03-24",{"date":33,"type":34},"2026-03-27","ACTUAL",{"date":36,"type":34},"2025-12-03",{"date":38,"type":20},"2027-07-01",{"name":40,"class":41},"Kind Pharmaceuticals LLC","INDUSTRY",1,{"id":44,"slug":4,"hasResults":10,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":42},"100630956","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",{"count":50,"type":20},300,[23],"This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)",[26],[28,29,55],"ESKD","2026-03-20",{"date":33,"type":34},{"date":59,"type":34},"2025-10-31",{"date":61,"type":20},"2027-04-30",{"name":40,"class":41},""]