Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-29 @ 10:33 AM
Study NCT ID:
NCT04464850
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Versus Oral Iron Therapy in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}, {'id': 'D007501', 'term': 'Iron'}, {'id': 'C031621', 'term': 'ferrous fumarate'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Maintenance hemodialysis patients who are eligible to enrol into the study according to inclusion and exclusion criteria will be start with 2-week run-in period before randomization. During this run-in period, all iron supplements that patients receive including oral and intravenous iron will be discontinued.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-07-06', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of epoetin dose', 'timeFrame': '24 weeks after randomization', 'description': 'Hemoglobin levels will be monitored and epoetin dose will be adjusted according to hemoglobin levels at 4, 12, 24 weeks after randomization.\n\nProtocols for epoetin dose adjustments are shown as follow. Hemoglobin levels (g/dl) Epoetin dose adjustment \\<9.0 Increased by 50% 9.0 to \\<10.0 Increased by 25% 10.0 to \\<11.5 No change 11.5 to \\<12.5 Decreased by 25%\n\n* 12.5 Decreased by 50%'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin levels', 'timeFrame': '4, 12, 24 weeks after randomization', 'description': 'Levels of hemoglobin concentration'}, {'measure': 'Erythropoietin resistance index', 'timeFrame': '4, 12, 24 weeks after randomization', 'description': 'Erythropoietin resistance index is calculated as the mean weekly epoetin dose per kg body weight divided by the average hemoglobin level'}, {'measure': 'Major cardiovascular events (MACE)', 'timeFrame': '24-week period after randomization', 'description': 'Major adverse cardiovascular events (MACE) is defined as a composite of nonfatal stroke, Nonfatal myocardial infarction, and cardiovascular death'}, {'measure': 'Unscheduled hospitalization', 'timeFrame': '24-week period after randomization', 'description': 'Numbers of any hospitalizations that is not planned'}, {'measure': 'Hospitalization due to infections', 'timeFrame': '24-week period after randomization', 'description': 'Numbers of any hospitalizations that is caused by infections'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': '4, 12, 24 weeks after randomization', 'description': 'Serum levels of high sensitivity c-reactive protein'}, {'measure': 'The kidney disease quality of life (KDQOL) instrument', 'timeFrame': '4, 12, 24 weeks after randomization', 'description': 'Quality of life will be assessed by the kidney disease quality of life (KDQOL) instrument'}, {'measure': 'Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)', 'timeFrame': '4, 12, 24 weeks after randomization', 'description': 'EQ-5D-5L is the instrument used to evaluate health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \\& discomfort, Anxiety \\& depression), each of which has five severity levels'}, {'measure': 'Cost-effectiveness of iron therapy', 'timeFrame': '4, 12, 24 weeks after randomization', 'description': 'The cost of iron therapy compared with the cost of epoetin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iron therapy', 'Hemodialysis', 'Iron status', 'Epoetin dose', 'Intravenous iron', 'Oral iron'], 'conditions': ['Hemodialysis Complication', 'Anemia', 'Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': 'This study is aim to compare the efficacy of intravenous versus oral iron therapy regarding the hemoglobin levels, iron status and erythropoietin dosage in maintenance hemodialysis patients', 'detailedDescription': 'Run-in phase: All eligible patients will enter run-in phase for 2 weeks. In this phase, all oral therapy that patients received before enrolment into the study will be discontinued.\n\nMasking: Opened label\n\nAllocation: Block of four randomization into 2 treatment arms: intravenous iron and oral iron\n\nSafety criteria: Study participants who meet the following criteria will be discontinued from the study. All patients data will be analyzed according to intention-to-treat principles.\n\n* Hemoglobin levels \\< 6.0 g/dl\n* Packed red cells transfusion is required\n* Serum ferritin \\>1,000 md/dl'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>18 years\n* Hemodialysis for at least 3 months\n* Hemoglobin levels between 8 and 11.5 g/dl inclusive\n* Transferrin saturation (TSAT) \\<50% and ferritin \\<800 mg/dl\n* Stable dose of epoetin of any types and iron therapy for at least 1 month\n\nExclusion Criteria:\n\n* History of iron allergy\n* Pregnant or lactating women\n* Patients with known hematologic disorders other than anemia of renal disease and iron deficiency anemia\n* Patients with hemoglobinopathy e.g., thalassemia\n* Patients with iron overload or hemochromatosis\n* Patients with gastrointestinal hemorrhage during 6 months before enrolment in to the study\n* Patients with current severe infection\n* Patients with any malignancies\n* Patients with severe psychiatric illness\n* Patients with any other medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes\n* Patients who currently receive medications that can altered gastrointestinal absorption of oral iron e.g., aluminum carbonate, aluminum hydroxide, chloramphenicol, dimercaprol"}, 'identificationModule': {'nctId': 'NCT04464850', 'acronym': 'IVO-IRON', 'briefTitle': 'Intravenous Versus Oral Iron Therapy in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'MED-2563-07092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous iron', 'description': 'Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day', 'interventionNames': ['Drug: Intravenous iron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral iron', 'description': 'Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day', 'interventionNames': ['Drug: Oral iron']}], 'interventions': [{'name': 'Intravenous iron', 'type': 'DRUG', 'otherNames': ['Venofer, Encifer'], 'description': 'Iron sucrose will be given by continuous infusion for 1 hour during the last 1 hour of dialysis session. Iron sucrose will be given for 24 weeks during study period.\n\nSerum ferritin will be monitored at 4, 12, and 24 weeks after randomization.\n\nThe dosage of intravenous iron will be adjusted according to serum ferritin levels as follows.\n\nSerum ferritin \\<500 mg/dl: iron sucrose 100 mg every 2 weeks Serum ferritin 500-800 mg/dl: iron sucrose 100 mg every 4 weeks Serum ferritin \\>800 mg/dl: discontinue iron sucrose', 'armGroupLabels': ['Intravenous iron']}, {'name': 'Oral iron', 'type': 'DRUG', 'otherNames': ['Ferli-6 (ferrous fumarate 200 mg, folic acid 0.5 mg, B6 5 mg)'], 'description': '1 tablet, three times a day, of iron fumarate will be prescribed for 24 weeks of study period.\n\nThe dosage of iron fumarate will be adjusted according to serum ferritin levels as follows.\n\nSerum ferritin will be monitored at 4, 12, and 24 weeks after randomization.\n\nSerum ferritin \\<500 mg/dl: iron fumarate 200 mg three times daily Serum ferritin 500-800 mg/dl: iron fumarate 200 mg once daily Serum ferritin \\>800 mg/dl: discontinue iron fumarate', 'armGroupLabels': ['Oral iron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Kajohnsak Noppakun, MD', 'role': 'CONTACT', 'email': 'kajohnsak.noppakun@cmu.ac.th', 'phone': '+66815953465'}, {'name': 'Tiranun Suriya, RN', 'role': 'CONTACT', 'email': 'tingsuri@hotmail.co.th', 'phone': '+66818812106'}], 'facility': 'Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'centralContacts': [{'name': 'Kajohnsak Noppakun, MD', 'role': 'CONTACT', 'email': 'kajohnsak.noppakun@cmu.ac.th', 'phone': '+66815953465'}, {'name': 'Tiranun Suriya, RN', 'role': 'CONTACT', 'email': 'tingsuri@hotmail.co.th', 'phone': '+66818812106'}], 'overallOfficials': [{'name': 'Kajohnsak Noppakun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instructor, Division of Nephrology, Department of Internal Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Request for individual participant data (IPD) has to be submitted to the Institutional Review Board (IRB) of Faculty of Medicine, Chiang Mai University, Chiang Mai, THAILAND.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Kajohnsak Noppakun', 'investigatorAffiliation': 'Chiang Mai University'}}}}