[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100630442","phase-3-a-study-of-and017-to-evaluate-efficacy-and-safety-in-patients-with-anemia-due-to-non-dialysis-dependent-chronic-kidney-disease-ndd-ckd-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":20,"type":21},240,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Anemia Due to Chronic Kidney Disease",[29,30],"anemia","CKD","RECRUITING","2026-03-24",{"date":34,"type":35},"2026-03-27","ACTUAL",{"date":37,"type":35},"2025-12-03",{"date":39,"type":21},"2027-07-01",{"name":41,"class":42},"Kind Pharmaceuticals LLC","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100630956","phase-3-a-study-of-and017-to-evaluate-efficacy-and-safety-in-dialysis-dependent-chronic-kidney-disease-dd-ckd-patients-with-anemia-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":52,"type":21},300,[24],"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)",[27],[29,30,57],"ESKD","2026-03-20",{"date":34,"type":35},{"date":61,"type":35},"2025-10-31",{"date":63,"type":21},"2027-04-30",{"name":41,"class":42}]