Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-30 @ 11:16 AM
Study NCT ID:
NCT06906835
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster randomization'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-03-26', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Erythropoietin resistance index (ERI) [non-inferiority]', 'timeFrame': '6 months', 'description': 'The erythropoietin resistance index (ERI, Unit/week/g/dL) is calculated by dividing the weekly body-weight-adjusted epoetin dose (international units per kilogram per week) by the hemoglobin concentration (grams per deciliter)\n\nThe pre-specified non-inferiority margin is 20% (approx. 160 Unit/week/g/dL)\n\nPre-specified subgroup analysis will be conducted: Patients with and without thalassemia trait will be separately analyzed'}], 'secondaryOutcomes': [{'measure': 'All cause death', 'timeFrame': '6 months'}, {'measure': 'Cardiovascular events', 'timeFrame': '6 months', 'description': 'includes fatal and non-fatal acute coronary syndrome, stroke, and heart failure.'}, {'measure': 'Blood Transfusions', 'timeFrame': '6 months', 'description': 'Indication of blood transfusion will be decided by attending physicians for symptomatic anemia.'}, {'measure': 'Hospitalizations', 'timeFrame': '6 months', 'description': 'all non-elective admissions will be counted'}, {'measure': 'Incidence of infection', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reticulocyte hemoglobin equivalent', 'Transferrin Saturation', 'Intravenous Iron Supplementation', 'Anemia in End Stage Renal Disease', 'Hemodialysis'], 'conditions': ['Hemodialysis', 'Anemia in End Stage Renal Disease']}, 'referencesModule': {'references': [{'pmid': '32043622', 'type': 'BACKGROUND', 'citation': 'Chinudomwong P, Binyasing A, Trongsakul R, Paisooksantivatana K. Diagnostic performance of reticulocyte hemoglobin equivalent in assessing the iron status. J Clin Lab Anal. 2020 Jun;34(6):e23225. doi: 10.1002/jcla.23225. Epub 2020 Feb 11.'}, {'pmid': '32612843', 'type': 'BACKGROUND', 'citation': 'Susantitaphong P, Siribumrungwong M, Takkavatakarn K, Chongthanakorn K, Lieusuwan S, Katavetin P, Tiranathanagul K, Lekhyananda S, Tungsanga K, Vanichakarn S, Eiam-Ong S, Praditpornsilpa K. Effect of Maintenance Intravenous Iron Treatment on Erythropoietin Dose in Chronic Hemodialysis Patients: A Multicenter Randomized Controlled Trial. Can J Kidney Health Dis. 2020 Jun 19;7:2054358120933397. doi: 10.1177/2054358120933397. eCollection 2020.'}, {'pmid': '33839163', 'type': 'BACKGROUND', 'citation': 'Babitt JL, Eisenga MF, Haase VH, Kshirsagar AV, Levin A, Locatelli F, Malyszko J, Swinkels DW, Tarng DC, Cheung M, Jadoul M, Winkelmayer WC, Drueke TB; Conference Participants. Controversies in optimal anemia management: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Conference. Kidney Int. 2021 Jun;99(6):1280-1295. doi: 10.1016/j.kint.2021.03.020. Epub 2021 Apr 8.'}, {'pmid': '34805628', 'type': 'BACKGROUND', 'citation': 'Wish JB, Anker SD, Butler J, Cases A, Stack AG, Macdougall IC. Iron Deficiency in CKD Without Concomitant Anemia. Kidney Int Rep. 2021 Aug 10;6(11):2752-2762. doi: 10.1016/j.ekir.2021.07.032. eCollection 2021 Nov.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age 18-80 years)\n* ESKD on chronic hemodialysis ≥ 6 months\n* EPO therapy ≥ 6 months\n* Hb \\< 13.0 g/dL in male, \\< 12.0 g/dL in female\n\nExclusion Criteria:\n\n* Serum ferritin \\> 800 ng/mL 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 /stroke in past 6 months\n* History of GI or external bleeding or receiving blood transfusion in past 6 months'}, 'identificationModule': {'nctId': 'NCT06906835', 'briefTitle': 'Comparing Reticulocyte Hemoglobin and Transferrin Saturation to Guide Iron Treatment in People on Dialysis', 'organization': {'class': 'OTHER', 'fullName': 'King Chulalongkorn Memorial Hospital'}, 'officialTitle': 'Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0202/67'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RET-He-Guided Iron Supplementation', 'description': 'Participants in this arm will receive intravenous (IV) iron therapy guided by reticulocyte hemoglobin equivalent (RET-He) levels.', 'interventionNames': ['Other: RET-He-Guided Iron Supplementation', 'Other: Common']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TSAT-Guided Iron Supplementation', 'description': 'Participants in this arm will receive IV iron therapy guided by transferrin saturation (TSAT) and serum ferritin.', 'interventionNames': ['Other: TSAT-Guided Iron Supplementation', 'Other: Common']}], 'interventions': [{'name': 'RET-He-Guided Iron Supplementation', 'type': 'OTHER', 'description': '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 \\< 26 pg: IV iron 100 mg weekly\n* RET-He ≥ 26 pg and \\< 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/mL: Discontinue iron supplementation to prevent iron overload', 'armGroupLabels': ['RET-He-Guided Iron Supplementation']}, {'name': 'TSAT-Guided Iron Supplementation', 'type': 'OTHER', 'description': '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 \\< 30% and ferritin \\< 200 ng/mL: IV iron 100 mg weekly\n* TSAT \\< 30% and ferritin 200-500 ng/mL: IV iron 100 mg every 2 weeks\n* TSAT \\< 30% and ferritin 500-800 ng/mL or TSAT 30-40%: IV iron 100 mg every 4 weeks\n* TSAT ≥ 40% or ferritin ≥ 800 ng/mL: Discontinue iron supplementation', 'armGroupLabels': ['TSAT-Guided Iron Supplementation']}, {'name': 'Common', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['RET-He-Guided Iron Supplementation', 'TSAT-Guided Iron Supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathumwan', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Jeerath Phannajit M.D.', 'role': 'CONTACT', 'email': 'jeerath.p@chula.ac.th', 'phone': '6622564000', 'phoneExt': '80901'}, {'name': 'Chalermchon Suttaluang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jeerath Phannajit M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paweena Susantitaphong M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'King Chulalongkorn Memorial Hospital'}], 'centralContacts': [{'name': 'Jeerath Jeerath Phannajit M.D.', 'role': 'CONTACT', 'email': 'jeerath.p@chula.ac.th', 'phone': '+6622564000', 'phoneExt': '80901'}, {'name': 'Chalermchon Suttaluang M.D.', 'role': 'CONTACT', 'email': 'chonharrychon@gmail.com'}], 'overallOfficials': [{'name': 'Paweena Susantitaphong M.D, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Center of Excellence for Metabolic Bone Disease in CKD patients, Chulalongkorn University'}, {'name': 'Jeerath Phannajit M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Clinical Epidemiology, Department of Medicine, King Chulalongkorn Memorial Hospital, Thai Red Cross'}, {'name': 'Chalermchon Suttaluang M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Department of Medicine, King Chulalongkorn Memorial Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'IPD are planned to be shared with a reasonable and relevant reason, please contact investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Chulalongkorn Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sysmex Asia Pacific', 'class': 'INDUSTRY'}, {'name': 'Center of Excellence for Metabolic Bone Disease in CKD patients, Faculty of Medicine, Chulalongkorn University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Clinical Epidemiology, Department of Medicine', 'investigatorFullName': 'Jeerath Phannajit', 'investigatorAffiliation': 'King Chulalongkorn Memorial Hospital'}}}}