[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anemia-of-chronic-kidney-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anemia-of-chronic-kidney-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,40,67,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100551953","phase-3-a-phase-3-study-of-efepoetin-alfa-for-treatment-of-anemia-in-patients-with-chronic-kidney-disease-on-dialysis-100551953",false,"NCT06466785","A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","A Phase III, Randomized, Investigator-Blinded, Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","Inclusion Criteria:\n\n1. Adult males and females ≥ 18 years old.\n2. Patient (or patient's legally acceptable representative) has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC) or institutional review board (IRB), after the nature of the study has been explained and the patient has had the opportunity to ask questions.\n3. Patient with stage 5 CKD defined by estimated GFR (eGFR, ≤15 mL\u002Fmin\u002F1.73m2) on adequate HD for a minimum of 12 weeks prior to Day 1. \\*CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines.\n4. Hemodialysis patients with single-pool Kt\u002FV ≥ 1.2 or urea reduction ratio ≥ 65%.\n\n   \\*Single-pool Kt\u002FV or urea reduction ratio will be based on results measured within 4 weeks prior to screening or during the screening period.\n5. Patients must be on stable doses of IV injections of ESA (including biosimilars) for at least 6 weeks prior to Day 1.\n\n   Minimum ESA dose;\n   * Epoetin alfa, epoetin beta, and epoetin kappa: ≥1,500 U\u002Fweek\n   * Darbepoetin alfa: ≥20 µg\u002Fweek\n   * Mircera®: ≥30 µg\u002F2 weeks\n6. Mean of the 2 most recent local laboratory Hb screening values obtained at least 6 days apart, must be 9.0 g\u002FdL to 12.0 g\u002FdL, inclusive, with a difference of ≤1.5 g\u002FdL between the highest and the lowest value.\n7. Patients with serum ferritin ≥100 ng\u002FmL at screening.\n8. Patients with transferrin saturation (TSAT) ≥20% at screening.\n9. Serum folate concentrations ≥lower limit of normal (LLN) at screening.\n10. Serum total vitamin B12 concentrations ≥LLN at screening.\n\nExclusion Criteria:\n\n1. Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease), or a C reactive protein level 40\\> mg\u002FL (high sensitive C-reactive protein level \\> 10 mg\u002FL).\n2. By history or current clinical evidence, patients with active acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection should be excluded. Routine screening for HBV, HCV, and human immunodeficiency virus (HIV) infection is not required in this protocol. Chronic HBV\u002FHCV infection with liver function tests (LFT) \\>3 times of normal are excluded. Known HIV positive patients are excluded.\n3. History or clinical evidence of cardiovascular, hematologic, hepatic, or any physical conditions that, in the opinion of the Investigator, would compromise participation in the study.\n4. Any of the following laboratory abnormalities at screening visit;\n\n   * Alanine transaminase (ALT) \\>3 x upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) \\>3 x ULN\n   * Total bilirubin \\>1.5 x ULN\n5. Chronic congestive heart failure (New York Heart Association class III or IV).\n6. High risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before Screening or during Screening.\n7. Uncontrolled hypertension defined as a sitting systolic blood pressure ≥170 mmHg and\u002For diastolic blood pressure ≥100 mmHg.\n8. History of active malignancy except for cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site.\n9. Patients with a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥1 g\u002FdL within the last 8 weeks prior to Screening.\n10. Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.\n11. Any prior functioning organ transplant or a scheduled organ transplantation, or anephric state (one or both kidneys).\n12. Planned elective surgery that could lead to significant blood loss during the study period.\n13. Hypoalbuminemia (Serum albumin \\\u003C2.5 g\u002FdL) at Screening Visit.\n14. Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1.\n15. Life expectancy of \\\u003C12 months.\n16. Cognitive or psychiatric condition rendering the patient unable to be cooperative with and complete study requirements.\n17. Hypersensitivity to any one of the investigational drugs or its excipients.\n18. Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to Screening, or blood transfusion is anticipated during the study period (excluding temporary blood transfusion given in case of blood loss due to accident or surgery).\n19. Immunosuppressive therapy (tacrolimus\u002Fcyclosporine, and other than corticosteroids for a chronic condition) within 12 weeks prior to Day 1.\n20. History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than \\>3 alcoholic beverages per day.\n21. Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study.\n22. Females of childbearing potential or males who are unable\u002Funwilling to take adequate contraceptive precautions defined by the protocol for the duration of the study and for at least 4 months for male subjects and 7 months for female patients after the end of the study. Females with a positive pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, plan to become pregnant in the next 12 months or are currently breastfeeding.\n23. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Sponsor or clinical research organization (CRO) employees directly involved in the conduct of the study.\n24. Patients with very limited functional capacity for which a target Hb value of 12 g\u002FdL may have a lower benefit\u002Frisk ratio.\n25. Any medical condition (patients weighing over 150 kg) that, in the opinion of the Investigator, may pose a safety risk to a patient in this study, may confound efficacy or safety assessment, or may interfere with study participation","ALL","18 Years",{"count":19,"type":20},429,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis",[26],"Anemia of Chronic Kidney Disease","RECRUITING","2026-05-20",{"date":30,"type":31},"2026-05-22","ACTUAL",{"date":33,"type":31},"2024-01-25",{"date":35,"type":20},"2028-03",{"name":37,"class":38},"Genexine, Inc.","INDUSTRY",58,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100478852","phase-4-a-post-marketing-surveillance-to-evaluate-the-safety-of-desidustat-for-the-treatment-of-anemia-in-subjects-with-chronic-kidney-disease-ckdreal-world-evidence-study-100478852","NCT05515367","A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)","A Phase 4,52 Week, Single Arm,Multicentre Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).","Inclusion Criteria:\n\n1. Male or female, ≥ 18 years of age.\n2. Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations must be 7.0-11.0 g\u002FdL (both inclusive) before the enrolment.\n3. Ability to understand and give informed consent for participation.\n4. No significant folate or Vitamin B12 deficiency.\n5. Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until End-of-study visit.\n6. For Subjects dependent on hemodialysis:\n\n   1. Must be receiving haemodialysis session ≥2 times in a week for at least 12 weeks prior to screening visit and have access consisting of an arteriovenous fistula, AV graft, or catheter (permanent\u002Ftemporary).\n   2. Subjects will be considered not treated with erythropoietin analogue (Epoetin and Darbepoetin) if they have not received erythropoietin analogue for at least 4 weeks and Mircera® for at least 8 weeks prior to screening visit. OR Subjects who are on ESA therapy must be on stable dose for 4 weeks prior to enrolment (≤30% of dose change).\n\nExclusion Criteria:\n\n1. Subjects who received red blood cell transfusion within 8 weeks prior to enrolment.\n2. Pre-dialysis subjects, who had prior exposure to ESA agents within 6 weeks prior to enrolment.\n3. In case of diabetes mellitus subjects, glycosylated haemoglobin (HbA1c) \\> 9 %.\n4. In case of hypertensive subjects, systolic and diastolic BP (Blood pressure) is \\>160 and 100 mm of Hg respectively or uncontrolled blood pressure.\n5. History of previous or concurrent cancer or renal transplant or severe allergic or hypersensitivity to investigational products and its excipients or chronic inflammatory disease (RA, Celiac disease, UC, Crohn's disease, Systemic Lupus Erythematosus \\[SLE\\]).\n6. Serologic status reflecting active Hepatits B or C infection or Human Immunodeficiency virus (HIV) infection.\n7. History of uncontrolled autoimmune haemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia\u002Fbleeding disorders or clinical conditions (e.g. gastrointestinal \\[GI\\] bleeding or constitutional disorders) that may increase risk of life-threatening bleeding.\u002F requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists or other medications within 28 days of the first dose of study drug that in the investigator's opinion, could compromise subject safety.\n8. Major surgery within 90 days and minor surgery within 30 days prior to the enrolment of the subject.\n9. Unable to swallow tablets or disease significantly affecting gastrointestinal function and\u002For inhibiting small intestine absorption such as; mal-absorption syndrome, resection of the small bowel or poorly controlled inflammatory bowel disease affecting the small intestine.\n10. History of myocardial infarction or stroke or intracranial haemorrhage within 6 months prior to enrolment.\n11. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the NYHA (New York Heart Association) classification.\n12. Current life-threatening illness, medical condition, systemic disorders (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) or laboratory abnormalities which, in the Investigator's opinion, could compromise the subject's safety.\n13. History of significant alcoholism or drug abuse within the past 1 year. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco\u002Fnicotine products (more than 10 times per day).\n14. History of difficulty with donating blood.\n15. History or presence of any clinically significant ECG abnormalities during screening.\n16. Participants who have participated in any drug research study other than the present trial within past 3 months.\n17. Female volunteers with following criteria will not be eligible:\n\n    1. History of pregnancy or lactation in the past 3 months.\n    2. Fertile female volunteers not protected against pregnancy by adequate long-term anti-fertility measures.\n    3. History of less than 1 year of menopause and not using adequate long-term antifertility measures.\n    4. Oral hormone replacement therapy.\n    5. Positive serum β-hCG level at the screening visit.\n    6. Pregnant and breastfeeding women.\n18. Abnormal baseline laboratory investigations as follows:\n\n    1. WBC count ≤3 x 103\u002FμL.\n    2. Platelets count ≤100 x 103\u002FμL.\n    3. Bilirubin ≥2.0 mg\u002FdL.\n    4. ALT and\u002For AST ≥2.5 times of the ULN.","85 Years",{"count":49,"type":20},1004,[51],"PHASE4","A Phase 4, 52 week, single arm, multicentre post marketing surveillance to evaluate the safety of Desidustat for the treatment of anemia in subjects with chronic kidney disease (CKD)",[54,26],"Chronic Kidney Diseases",[56],"Real World Evidence Study","2025-01-21",{"date":59,"type":31},"2025-01-22",{"date":61,"type":31},"2023-04-20",{"date":63,"type":20},"2025-11-30",{"name":65,"class":38},"Zydus Lifesciences Limited",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":66},"100543151","phase-3-comparative-study-of-two-recombinant-human-erythropoietin-products-in-chronic-kidney-disease-patients-100543151","NCT06352138","Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients","Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i\u002Fv Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease","ENCASE","Inclusion Criteria:\n\n* Stage V Chronic kidney disease undergoing hemodialysis\n\nExclusion Criteria:\n\n* Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies","65 Years",{"count":77,"type":20},280,[23],"Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis",[26],"NOT_YET_RECRUITING","2024-08-15",{"date":84,"type":31},"2024-08-19",{"date":86,"type":20},"2025-07",{"date":88,"type":20},"2027-03",{"name":90,"class":38},"Megalabs",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":66},"100551680","clinical-validation-of-the-management-process-for-renal-anemia-in-maintenance-hemodialysis-patients-100551680","NCT06463236","Clinical Validation of the Management Process for Renal Anemia in Maintenance Hemodialysis Patients","Inclusion Criteria:\n\n① Age over 18 years old; ② Receive regular hemodialysis at least twice a week for at least 3 months, and have no plans to stop hemodialysis within 6 months since the start of the trial; ③ The patient voluntarily participated in this study.\n\nExclusion Criteria:\n\n* Patients who have planned to undergo kidney transplantation or terminate hemodialysis during the study period; ② Previous history of bone marrow hematopoietic system diseases, such as combined myelodysplastic syndrome, multiple myeloma, and other diseases; ③ Any known hereditary blood disease, such as thalassemia, sickle cell anemia, pure red blood cell aplasia, etc.; ④ Active or chronic gastrointestinal bleeding; ⑤ There was a severe infection within one week prior to screening.",{"count":98,"type":20},1296,[100],"NA","This test aims to verify that the management process of renal anemia in maintenance hemodialysis patients can improve the hemoglobin compliance rate better than that of anemia management by primary doctors, and promote the system at the grassroots level to guide primary doctors in anemia management and improve the management standard of renal anemia in maintenance hemodialysis patients through prospective randomized controlled trials. To improve the anemia compliance rate of maintenance hemodialysis patients, and to improve the basic doctors' grasp of the anemia management guidelines, consensus and standard operating procedures.",[26],"2024-06-12",{"date":105,"type":31},"2024-06-17",{"date":107,"type":20},"2024-06-14",{"date":109,"type":20},"2025-08-31",{"name":111,"class":112},"Hong Daqing","OTHER"]