[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-anemia-in-non-dialysis-chronic-kidney-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-anemia-in-non-dialysis-chronic-kidney-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100599060","phase-4-enarodustat-tablets-at-different-initial-doses-for-anemia-in-non-dialysis-ckd-patients-100599060",false,"NCT07079579","Enarodustat Tablets at Different Initial Doses for Anemia in Non-dialysis CKD Patients","A Prospective, Single-arm, Open-label Study to Evaluate Different Initial Doses of Enarodustat Tablets for the Treatment of Anemia in Patients With Non-dialysis Chronic Kidney Disease","Inclusion Criteria:\n\n* Patients who meet all the following criteria can be enrolled in this study:\n\n  1. Male or female patients aged 18-75 years (inclusive);\n  2. Body weight: 45-100 kg (inclusive);\n  3. Stage 3-5 non-dialysis CKD complicated with renal anemia during the screening period, with an eGFR of 10-60 mL\u002Fmin\u002F1.73 m2 (exclusive) (calculated by CKD-EPI equation);\n  4. Criteria for Hb levels at screening and baseline\n\n  \u003C!-- -->\n\n  1. ESA-naïve population: Patients who do not receive ESA treatment in the past 12 weeks, with the Hb level greater than or equal to 70 g\u002FL and less than 100 g\u002FL;\n  2. ESA-treated population: Patients who have received ESA treatment for at least 8 weeks, with the Hb level greater than or equal to 100 g\u002FL and less than or equal to 120 g\u002FL; 5.Female patients shall take contraceptive measures during the study; Patients who voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients who meet any one of the following criteria shall be excluded from the study:\n\n  1. Patients with SF ≤100 μg\u002FL and TSAT ≤20% at screening;\n  2. Patients who are expected to start renal replacement therapy in the next 6 months as judged by the investigator;\n  3. Patients with systemic hematologic disorders (e.g., myelodysplastic syndrome and aplastic anemia, etc.) or non-CKD-related anemia (hemolytic anemia, hemorrhagic anemia, cancer related anemia, etc.);\n  4. Patients with a 1.5-fold increase in serum creatinine during the screening period;\n  5. Patients who have received hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI) within 8 weeks before screening;\n  6. Patients with polycystic kidney disease;\n  7. Patients with poorly controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at the screening visit);\n  8. Patients with congestive cardiac failure (New York Heart Association \\[NYHA\\] Class III or above) or unstable angina;\n  9. Patients who have experienced myocardial infarction, transient ischemic attack, cerebral infarction (except asymptomatic cerebral infarction) or venous thromboembolism (pulmonary embolism or deep vein thrombosis) from 24 weeks before screening to the first dose of the investigational drug;\n  10. Patients with severe hepatobiliary disorders (e.g., AST or ALT \\>2.5 × upper limit of normal (ULN) at the screening visit, patients with hepatic cirrhosis or total bilirubin ≥1.5 × ULN at the screening visit);\n  11. Patients who have received red blood cell transfusion from 12 weeks before screening to the first dose of the investigational drug;\n  12. Patients who have received growth hormone, thyroid hormone, testosterone enanthate or methandienone from 12 weeks before screening to the first dose of the investigational drug;\n  13. Patients who will undergo elective ophthalmic surgery in the next 6 months;\n  14. Patients with severe hyperparathyroidism (e.g., iPTH ≥500 pg\u002FmL at the screening visit);\n  15. Patients with severe infections (e.g., active pulmonary tuberculosis and fungal infection, etc.);\n  16. Patients suspected of having other non-infectious chronic inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis and coeliac disease, etc.);\n  17. Patients with a positive result for HIV, HCV or Treponema pallidum antibody, or with a positive result for HBsAg and HBV DNA ≥1,000 U\u002FmL;\n  18. Patients with a history of malignant tumors (including hematological malignancies) in the past 5 years;\n  19. Patients with a history of severe drug allergy (e.g., anaphylactic shock) or hypersensitivity to other HIF-PHIs;\n  20. Patients with a history of drug or alcohol abuse in the past two years;\n  21. Patients who have received other investigational drugs (or study drugs) or received investigational medical devices (or study devices) from 12 weeks before the screening visit to the first dose of the investigational drug, or are participating in other interventional clinical studies (medical behaviors beyond routine diagnosis and treatment, implemented for study purposes) and receiving treatment;\n  22. Patients who are pregnant, lactating or have the possibility of pregnancy (based on the results of the pregnancy test at the screening visit, the investigator cannot rule out the possibility of pregnancy);\n  23. Patients with any medical conditions that, in the investigator's judgment, may pose a safety risk, may confound efficacy or safety evaluation, or may interfere with their participation in the study.","ALL","18 Years","75 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","To evaluate the rationality of different initial doses of enarodustat for the treatment of anemia in ND-CKD patients",[27],"Renal Anemia in Non-dialysis Chronic Kidney Disease",[27,29],"Enarodustat","NOT_YET_RECRUITING","2025-07-14",{"date":33,"type":34},"2025-07-23","ACTUAL",{"date":36,"type":21},"2025-08",{"date":38,"type":21},"2027-12",{"name":40,"class":41},"Shenzhen Salubris Pharmaceuticals Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100588822","phase-4-two-different-regiments-of-pegmolesatide-for-anemia-in-patients-with-chronic-kidney-disease-not-receiving-dialysis-100588822","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.","80 Years",{"count":52,"type":21},160,[24],"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.",[27],[57],"Anemia","2025-04-23",{"date":60,"type":34},"2025-04-27",{"date":62,"type":21},"2025-05",{"date":64,"type":21},"2026-11",{"name":66,"class":67},"The First Affiliated Hospital of Dalian Medical University","OTHER"]