[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630442":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":55,"studyPopulation":55,"armGroups":62,"interventions":73,"overallOfficials":82,"centralContacts":86,"locations":91,"responsibleParty":110,"collaborators":55,"id":112,"slug":55,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":55,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":55,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":94,"whyStopped":55,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Kind Pharmaceuticals LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluate the efficacy of AND017 compared with the active control in maintaining Hemoglobin (Hb) levels in patients with anemia due to CKD","The mean Hb levels averaged over Week 23-27","From Week 23 to Week 27",[14,18,22,26,29,32,35,37,39,42,44,46,48,51,53],{"measure":15,"description":16,"timeFrame":17},"The percentage of responders","Responder is defined as: for participants with baseline Hb ≥ 9.0 g\u002FdL, mean Hb ≥ 10.0 g\u002FdL and a change from baseline ≥ -1.0 g\u002FdL during Weeks 23-27; for participants with baseline Hb \\\u003C 9.0 g\u002FdL, an increase in Hb from baseline ≥ 1.0 g\u002FdL (for) during Weeks 3-27","From baseline to Week 27",{"measure":19,"description":20,"timeFrame":21},"Percentage of participants that maintained Hb level over target lower limit","Percentage of participants with mean Hb ≥ 10.0 g\u002FdL averaged over Weeks 5-27","From Week 5 to Week 27",{"measure":23,"description":24,"timeFrame":25},"Maintenance of Hb within 10.0-12.0 g\u002FdL after initial achievement ≥10.0 g\u002FdL during the entire study treatment period","During entire study treatment period, the percentage of participants in which Hb, after first reaching ≥ 10.0 g\u002FdL, is maintained within the target range of 10.0-12.0 g\u002FdL (inclusive)","From baseline to Week 53",{"measure":27,"description":28,"timeFrame":25},"Incidence of extreme Hb levels of ≥13.0 g\u002FdL or \u003C7.5 g\u002FdL during the entire study treatment period","During the entire study treatment period, the percentage of participants in which Hb is ≥ 13.0 g\u002FdL or \\\u003C 7.5 g\u002FdL",{"measure":30,"description":31,"timeFrame":25},"Incidence of excessive erythropoiesis","During the entire study treatment period, the percentage of participants with an Hb increase ≥ 1.0 g\u002FdL within any 2-week period and an Hb increase ≥ 2.0 g\u002FdL within any 4-week period respectively",{"measure":33,"description":34,"timeFrame":17},"The cumulative incidence of Hb non-response","The cumulative incidence of Hb non-response is defined as Hb \\\u003C 10.0 g\u002FdL and an increase from baseline \\\u003C 1.0 g\u002FdL averaged over Weeks 5-27.",{"measure":36,"description":36,"timeFrame":17},"Mean Hb change from baseline averaged over Weeks 5-27",{"measure":38,"description":38,"timeFrame":17},"Mean Hb change from baseline averaged over Weeks 23-27",{"measure":40,"description":40,"timeFrame":41},"Mean Hb change from baseline averaged over Weeks 13-17","From baseline to Week 17",{"measure":43,"description":43,"timeFrame":25},"Mean Hb change from baseline averaged over Weeks 27-53",{"measure":45,"description":45,"timeFrame":25},"Mean Hb change from baseline averaged over Weeks 49-53",{"measure":47,"description":47,"timeFrame":25},"During the entire treatment period, mean Hb at each visit",{"measure":49,"description":50,"timeFrame":25},"The use of intravenous iron during the entire study treatment period","The percentage of participants that have received intravenous iron during the entire study treatment period",{"measure":52,"description":52,"timeFrame":25},"The mean weekly dose of intravenous iron during the entire treatment period",{"measure":54,"description":54,"timeFrame":25},"The time to first initiation of intravenous iron during the entire treatment period",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":55,"primaryPurpose":59,"observationalModel":55,"timePerspective":55,"maskingInfo":60},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":61,"maskingDescription":55,"whoMasked":55},"NONE",[63,68],{"label":64,"type":65,"description":55,"interventionNames":66},"AND017","EXPERIMENTAL",[67],"Drug: AND017",{"label":69,"type":70,"description":55,"interventionNames":71},"Erythropoiesis Stimulating Agents (ESA)","ACTIVE_COMPARATOR",[72],"Drug: ESA",[74,78],{"type":75,"name":64,"description":76,"armGroupLabels":77,"otherNames":55},"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",[64],{"type":75,"name":79,"description":80,"armGroupLabels":81,"otherNames":55},"ESA","ESA injection and dose based on package insert and local practice",[69],[83],{"name":84,"affiliation":5,"role":85},"Yusha Zhu, MD, PhD","STUDY_DIRECTOR",[87],{"name":84,"role":88,"phone":89,"phoneExt":55,"email":90},"CONTACT","646-725-2552","yushazhu@kindpharmaceutical.com",[92],{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Peking University People's Hospital","RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":101,"coordinates":102},"Point",[103,104],116.39723,39.9075,{"lat":104,"lon":103},[107],{"name":108,"role":109,"phone":55,"phoneExt":55,"email":55},"Li Zuo, MD","PRINCIPAL_INVESTIGATOR",{"type":111,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","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":122,"type":123},240,"ESTIMATED","INTERVENTIONAL",[126],"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",[129],"Anemia Due to Chronic Kidney Disease",[131,132],"anemia","CKD","2026-03-24",{"date":135,"type":136},"2026-03-27","ACTUAL",{"date":138,"type":136},"2025-12-03",{"date":140,"type":123},"2027-07-01",{"name":5,"class":6},1]