[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585781":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":33,"centralContacts":46,"locations":55,"responsibleParty":72,"collaborators":75,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":25,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":25,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":57,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"King Chulalongkorn Memorial Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"RET-He-Guided Iron Supplementation","EXPERIMENTAL","Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels.",[13,14],"Other: RET-He-Guided Iron Supplementation","Other: Common",{"label":16,"type":17,"description":18,"interventionNames":19},"TSAT-Guided Iron Supplementation","ACTIVE_COMPARATOR","Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin.",[20,14],"Other: TSAT-Guided Iron Supplementation",[22,26,29],{"type":6,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels.\n\nIron dosing will follow a protocol based on RET-He values:\n\n* RET-He \\\u003C 26 pg: IV iron 100 mg weekly\n* RET-He ≥ 26 pg and \\\u003C 30 pg: IV iron 100 mg every 2 weeks\n* RET-He ≥ 30 pg and ≤ 36 pg: IV iron 100 mg every 4 weeks\n* RET-He \\> 36 pg or ferritin ≥ 800 ng\u002FmL: Discontinue iron supplementation to prevent iron overload",[9],null,{"type":6,"name":16,"description":27,"armGroupLabels":28,"otherNames":25},"Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin, as per the Thai Clinical Practice Guidelines for Anemia in CKD (2021).\n\nIron dosing will follow this TSAT-based protocol:\n\n* TSAT \\\u003C 30% and ferritin \\\u003C 200 ng\u002FmL: IV iron 100 mg weekly\n* TSAT \\\u003C 30% and ferritin 200-500 ng\u002FmL: IV iron 100 mg every 2 weeks\n* TSAT \\\u003C 30% and ferritin 500-800 ng\u002FmL or TSAT 30-40%: IV iron 100 mg every 4 weeks\n* TSAT ≥ 40% or ferritin ≥ 800 ng\u002FmL: Discontinue iron supplementation",[16],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":25},"Common","All participants will receive erythropoiesis-stimulating agents (ESAs) according to a standardized dose adjustment protocol based on hemoglobin levels.\n\nOral iron supplements will be discontinued.",[9,16],[34,38,42],{"name":35,"affiliation":36,"role":37},"Paweena Susantitaphong M.D, Ph.D.","Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University","STUDY_CHAIR",{"name":39,"affiliation":40,"role":41},"Jeerath Phannajit M.D.","Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross","STUDY_DIRECTOR",{"name":43,"affiliation":44,"role":45},"Chalermchon Suttaluang M.D.","Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital","PRINCIPAL_INVESTIGATOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Jeerath Jeerath Phannajit M.D.","CONTACT","+6622564000","80901","jeerath.p@chula.ac.th",{"name":43,"role":49,"phone":25,"phoneExt":25,"email":54},"chonharrychon@gmail.com",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":25,"geoPoint":25,"contacts":63},"RECRUITING","Pathumwan","Bangkok","10330","Thailand","TH",[64,66,68,70],{"name":39,"role":49,"phone":65,"phoneExt":51,"email":52},"6622564000",{"name":67,"role":45,"phone":25,"phoneExt":25,"email":25},"Chalermchon Suttaluang",{"name":39,"role":69,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":71,"role":69,"phone":25,"phoneExt":25,"email":25},"Paweena Susantitaphong M.D., Ph.D.",{"type":45,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Jeerath Phannajit","Chief, Division of Clinical Epidemiology, Department of Medicine",[76,79],{"name":77,"class":78},"Sysmex Asia Pacific","INDUSTRY",{"name":80,"class":6},"Chulalongkorn University","100585781","comparing-reticulocyte-hemoglobin-and-transferrin-saturation-to-guide-iron-treatment-in-people-on-dialysis-100585781",false,"NCT06906835","Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis","Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult (age 18-80 years)\n* ESKD on chronic hemodialysis ≥ 6 months\n* EPO therapy ≥ 6 months\n* Hb \\\u003C 13.0 g\u002FdL in male, \\\u003C 12.0 g\u002FdL in female\n\nExclusion Criteria:\n\n* Serum ferritin \\> 800 ng\u002FmL or TSAT \\> 40%\n* Active infection or malignancy\n* Hematologic disease including thalassemia major, hemolysis, myelofibrosis or myelodysplastic disease\n* History of marrow suppressive or immunosuppressive medications in past 6 months\n* History of active heart failure and recent myocardial infarction \u002Fstroke in past 6 months\n* History of GI or external bleeding or receiving blood transfusion in past 6 months","ALL","18 Years","80 Years",{"count":92,"type":93},160,"ESTIMATED","INTERVENTIONAL",[96],"NA","The goal of this clinical trial is to find out which method is better for guiding iron treatment in adult patients with end-stage kidney disease (ESKD) on hemodialysis who have anemia.\n\nThe main questions it aims to answer are:\n\nCan using reticulocyte hemoglobin equivalent (RET-He) to guide intravenous (IV) iron treatment be as effective as using transferrin saturation (TSAT)?\n\nDoes the method used to guide iron treatment affect outcomes such as death, heart problems, hospitalizations, infections, or the need for blood transfusions?\n\nResearchers will compare RET-He-guided iron treatment with TSAT-guided iron treatment to see if RET-He works just as well and has similar or better outcomes.\n\nParticipants will:\n\nReceive IV iron based on either RET-He or TSAT levels\n\nHave blood tests done at the start, 3 months, and 6 months\n\nHave their doses of iron and erythropoietin (a medication to treat anemia) adjusted based on the assigned protocol\n\nBe monitored for clinical outcomes such as hospitalization, heart events, and infections",[99,100],"Hemodialysis","Anemia in End Stage Renal Disease",[102,103,104,100,99],"Reticulocyte hemoglobin equivalent","Transferrin Saturation","Intravenous Iron Supplementation","2025-04-01",{"date":107,"type":108},"2025-04-04","ACTUAL",{"date":110,"type":108},"2025-01-31",{"date":112,"type":93},"2025-09-30",{"name":5,"class":6},1]