[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588822":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":35,"responsibleParty":40,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":35,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":35,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":35,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":35},{"fullName":5,"class":6},"The First Affiliated Hospital of Dalian Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pegmolesatide optimize medication regimen group","EXPERIMENTAL","initial phase：Body weight ≤60kg, initial dose 2.0mg; Body weight \\> 60kg, initial dose 3.2mg, once every 4 weeks by subcutaneous injection.\n\nAdjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection.",[13],"Drug: Pegmolesatide",{"label":15,"type":16,"description":17,"interventionNames":18},"Pegmolesatide standard medication regimen group","ACTIVE_COMPARATOR","initial phase：0.04mg\u002Fkg body weight, once every 4 weeks by subcutaneous injection.\n\nAdjustment phase：based on Hb levels and its changes every 4 weeks, once a month by subcutaneous injection.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pegmolesatide","Pegmolesatide Injection: Specification 1mL: 4.0mg (National Medical Products Administration Approval No. H20230020), administered once every 4 weeks",[9,15],[26],"EPO-018B",[28],{"name":29,"affiliation":5,"role":30},"Hongli Lin, M.D.","PRINCIPAL_INVESTIGATOR",[32,37],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","13332268576",null,"linhongli@vip.163.com",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":35},"Jilin Chen, M.D.","18098875658",{"type":41,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[43],{"name":44,"class":45},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY","100588822","phase-4-two-different-regiments-of-pegmolesatide-for-anemia-in-patients-with-chronic-kidney-disease-not-receiving-dialysis-100588822",false,"NCT06946394","Two Different Regiments of Pegmolesatide for Anemia in Patients With Chronic Kidney Disease Not Receiving Dialysis","Application of Pegmolesatide in Renal Anemia: the Effectiveness and Safety of Switching to Two Different Regimens of Pegmolesatide in Patients With Non Dialysis CKD Treated With rhuEPO or HIF-PHI","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 80 years old, gender not limited;\n2. Weight ≥ 45kg; Body Mass Index (BMI) ≥ 18.5kg\u002Fm\\^2;\n3. Diagnosed with CKD ≥ 6 months and estimated glomerular filtration rate (eGFR) ≥ 15mL\u002Fmin\u002F1.73m\\^2 before enrollment, and\\\u003C60 mL\u002Fmin\u002F1.73m\\^2 (estimated GFR using CKD-EPI formula), with no expected renal replacement therapy plan during the study period;\n4. rHuEPO or HIF-PHI should be used for ≥ 4 weeks and ≤ 12 weeks;\n5. During the 28days and 3days before randomization, with Hb ≥ 70g\u002FL and \\\u003C 110g\u002FL;\n6. Understand the research procedure and voluntarily sign an informed consent form (ICF) in writing.\n\nExclusion Criteria:\n\n1. Known to have hematological disorders or other diseases that cause anemia other than chronic kidney disease (CKD), such as primary pure red cell aplasia (PRCA), homozygous sickle cell disease, thalassemia\u002FCooley's anemia, multiple myeloma, hemolytic anemia, and myelodysplastic syndrome, or malignant tumors;\n2. Known to be allergic to iron agents or polyethylene glycol;\n3. Received red blood cell or whole blood transfusion therapy within the three months prior to randomization;\n4. Have received oral or intravenous immunosuppressive or glucocorticoid therapy within the 12 weeks prior to randomization;\n5. Individuals with poor blood pressure control;\n6. C-reactive protein ≥ 30mg\u002FL within the first 3 days of randomization;\n7. Pregnant and lactating women, women of childbearing age who have a positive urine β - HCG test result before the trial, or those who have a pregnancy plan during the study period;\n8. Assessment of cardiac function level III or IV within the first 3 days of randomization;\n9. Within the first 3 days of randomization, the liver function was assessed as Grade C;\n10. Researchers believe that subjects with any other factors that are not suitable for participating in this trial.","ALL","18 Years","80 Years",{"count":57,"type":58},160,"ESTIMATED","INTERVENTIONAL",[61],"PHASE4","This was a multicenter, randomized, open label, non inferiority clinical study. It consisted of a 24-week treatment period (0-24 weeks) and a 24-week extension period (25-48 weeks). About 160 patients which had received Recombinant human erythropoietin (rHuEPO) or Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) treatment were randomized in a 1:1 ratio to receive Pegmolesatide with different administration regimens.",[64],"Renal Anemia in Non-dialysis Chronic Kidney Disease",[66],"Anemia","NOT_YET_RECRUITING","2025-04-23",{"date":70,"type":71},"2025-04-27","ACTUAL",{"date":73,"type":58},"2025-05",{"date":75,"type":58},"2026-11",{"name":5,"class":6}]