[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630442":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":37,"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":40,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Kind Pharmaceuticals LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AND017","EXPERIMENTAL",null,[13],"Drug: AND017",{"label":15,"type":16,"description":11,"interventionNames":17},"Erythropoiesis Stimulating Agents (ESA)","ACTIVE_COMPARATOR",[18],"Drug: ESA",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","AND017 capsules administered orally with a starting dose of 8 mg TIW for ESA naive patients or 10 mg TIW for ESA treated patients",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"ESA","ESA injection and dose based on package insert and local practice",[15],[29],{"name":30,"affiliation":5,"role":31},"Yusha Zhu, MD, PhD","STUDY_DIRECTOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":11,"email":36},"CONTACT","646-725-2552","yushazhu@kindpharmaceutical.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Peking University People's Hospital","RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":55,"phone":11,"phoneExt":11,"email":11},"Li Zuo, MD","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":69,"type":70},240,"ESTIMATED","INTERVENTIONAL",[73],"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",[76],"Anemia Due to Chronic Kidney Disease",[78,79],"anemia","CKD","2026-03-24",{"date":82,"type":83},"2026-03-27","ACTUAL",{"date":85,"type":83},"2025-12-03",{"date":87,"type":70},"2027-07-01",{"name":5,"class":6},1]