[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579949":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":33,"responsibleParty":41,"collaborators":45,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":33,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":33,"enrollmentInfo":67,"targetDuration":33,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":82,"whyStopped":33,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":33},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Iron isomaltoside Group","EXPERIMENTAL","Intravenous infusion of 1000mg iron isomaltoside as a single dose for over 15min. Iron isomaltoside 1000mg was diluted in 100ml of 0.9% saline.",[13],"Drug: Iron isomaltoside",{"label":15,"type":16,"description":17,"interventionNames":18},"Ferrous succinate Group","ACTIVE_COMPARATOR","Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks(containing iron element 7840mg in total).",[19],"Drug: Ferrous succinate",[21,27],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Iron isomaltoside",[9],[26],"Intravenous iron isomaltoside",{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Ferrous succinate","Patients received ferrous succinate treatment orally given as 200mg twice a day for 8 weeks.",[15],[32],"Oral ferrous succinate",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Jingyuan Xie","CONTACT","+862164370045","665272","nephroxie@163.com",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"SPONSOR_INVESTIGATOR","Xie Jingyuan, MD","professor",[46,48,50,53,55],{"name":47,"class":6},"RenJi Hospital",{"name":49,"class":6},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"name":51,"class":52},"Songjiang Hospital, Shanghai Jiao Tong University School of Medicine","UNKNOWN",{"name":54,"class":6},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"name":56,"class":57},"Chinese People's Liberation Army No 455 Hospital","OTHER_GOV","100579949","phase-4-iron-isomaltoside-for-the-treatment-of-anemia-in-peritoneal-dialysis-patients-100579949",false,"NCT06830941","Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients","Efficacy and Safety of Iron Isomaltoside in the Treatment of Peritoneal Dialysis Patients with Renal Related Anemia: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Males or females who are ≥ 18 years and on PD treatment for ≥90 days, body weight≥50Kg\n2. Hemoglobin(Hb）≤110 g\u002FL at screening phase\n3. Serum ferritin(SF）≤200 μg\u002FL or transferrin saturation(TSAT）≤20% at screening phase\n4. No oral or intravenous iron use within 4 weeks prior to screening.\n5. No hypoxia-inducible factor prolyl hydroxylase inhibitor（HIF-PHI）used or other erythropoiesis-stimulating agent（ESA）except for erythropoietin (EPO) used in the past 4 weeks prior to screening\n6. Stable doses of erythropoiesis-stimulating agents (ESA) with a change of dose ≤20% during the past 4 weeks.\n7. Willing to participate and signed the informed consent form\n\nExclusion Criteria:\n\n1. Anemia predominantly caused by other diseases rather than renal diseases according to the investigator's judgement. (eg. bleeding, hematological diseases, anemia due to autoimmune diseases)\n2. History of disturbances in iron utilisation.(eg. hemochromatosis and hemosiderosis）\n3. Anemia due to lack of folate or vitamin B12：folate\\\u003C6.8nmol\u002FL（3ng\u002Fml）and(or) Vitamin B12\\\u003C74pmol\u002FL（100pg\u002Fml）at screening phase\n4. Histories of serious allergies to iron\n5. Obvious liver dysfunction：ALT\\>3×ULN and\u002For AST\\>3×ULN，or total bilirubin\\>1.5×ULN\n6. Active acute or chronic infection(clinically diagnosed)\n7. Uncontrolled secondary hyperparathyroidism：PTH or iPTH\\>9×ULN；\n8. History of malignancy within 5 years\n9. Acute coronary syndrome, strokes (except for lacunar cerebral infarction), serious thromboembolism (eg. DVT or PE) within 6 months before the screening period\n10. NYHA grade III or IV of congestive heart failure or severe arrythmia(including ventricular tachycardia, ventricular fibrillation, AV-block III etc.) within 6 months before screening\n11. Pregnant or during lactation period or not willing to get contraception\n12. Planning to receive renal transplantation within 2 months\n13. Accepted blood transfusion within 3 months.\n14. Serum ferritin，SF\\>500 μg\u002FL\n15. Planning to recieve the treatment as operations, chemotherapies or radiotherapies etc. during the research period\n16. Other situations not suitable for inclusion decided by researchers. Rescreening is allowed if it failed in the first time of screening.","ALL","18 Years",{"count":68,"type":69},124,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","This is a prospective multicenter randomized controlled clinical study. The goal of this clinical trial is to learn if intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.\n\nThe main questions to answer are:\n\n* Changes in hemoglobin concentration from baseline to week 8 after the use of single dose intravenous iron isomaltoside injection in peritoneal dialysis patients with renal anemia.\n* If intravenous iron isomaltoside injection use is equally effective and safe for the treatment of renal anemia in peritoneal dialysis patients compared with oral ferrous succinate tablets.\n\nParticipants will:\n\n* be randomized 1:1 to two groups, either Iron isomaltoside Group (Group A, experimental group) or Ferrous succinate Group (Group B, control group).\n* Patients in Iron isomaltoside Group will receive a single dose of intravenous iron isomaltoside injection, the dose of which is set at 1000 mg. Patients in Ferrous succinate Group will receive ferrous succinate treatment orally given as 200mg twice a day for 8 weeks (containing iron element 7840mg in total).\n* Patients will be followed up for 8 weeks.",[75,76],"Renal Anemia","Peritoneal Dialysis (PD)",[78,79,80,81],"peritoneal dialysis","renal anemia","iron isomaltoside","iron treatment","NOT_YET_RECRUITING","2025-02-13",{"date":85,"type":86},"2025-02-17","ACTUAL",{"date":88,"type":69},"2025-02-15",{"date":90,"type":69},"2027-12-31",{"name":43,"class":6}]