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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
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.
Masking: Opened label
Allocation: Block of four randomization into 2 treatment arms: intravenous iron and oral iron
Safety 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous iron | Experimental | Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day |
|
| Oral iron | Active Comparator | Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous iron | Drug | 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. Serum ferritin will be monitored at 4, 12, and 24 weeks after randomization. The dosage of intravenous iron will be adjusted according to serum ferritin levels as follows. Serum 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of epoetin dose | Hemoglobin levels will be monitored and epoetin dose will be adjusted according to hemoglobin levels at 4, 12, 24 weeks after randomization. Protocols 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%
| 24 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin levels | Levels of hemoglobin concentration | 4, 12, 24 weeks after randomization |
| Erythropoietin resistance index | Erythropoietin resistance index is calculated as the mean weekly epoetin dose per kg body weight divided by the average hemoglobin level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kajohnsak Noppakun, MD | Contact | +66815953465 | kajohnsak.noppakun@cmu.ac.th | |
| Tiranun Suriya, RN | Contact | +66818812106 | tingsuri@hotmail.co.th |
| Name | Affiliation | Role |
|---|---|---|
| Kajohnsak Noppakun, MD | Instructor, Division of Nephrology, Department of Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University | Recruiting | Chiang Mai | 50200 | Thailand |
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.
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000747 | Anemia, Hypochromic |
| D000090463 | Iron Deficiencies |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| D007501 | Iron |
| C031621 | ferrous fumarate |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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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.
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|
|
| Oral iron | Drug | 1 tablet, three times a day, of iron fumarate will be prescribed for 24 weeks of study period. The dosage of iron fumarate will be adjusted according to serum ferritin levels as follows. Serum ferritin will be monitored at 4, 12, and 24 weeks after randomization. Serum 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 |
|
|
| 4, 12, 24 weeks after randomization |
| Major cardiovascular events (MACE) | Major adverse cardiovascular events (MACE) is defined as a composite of nonfatal stroke, Nonfatal myocardial infarction, and cardiovascular death | 24-week period after randomization |
| Unscheduled hospitalization | Numbers of any hospitalizations that is not planned | 24-week period after randomization |
| Hospitalization due to infections | Numbers of any hospitalizations that is caused by infections | 24-week period after randomization |
| C-reactive protein (CRP) | Serum levels of high sensitivity c-reactive protein | 4, 12, 24 weeks after randomization |
| The kidney disease quality of life (KDQOL) instrument | Quality of life will be assessed by the kidney disease quality of life (KDQOL) instrument | 4, 12, 24 weeks after randomization |
| Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels) | 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 | 4, 12, 24 weeks after randomization |
| Cost-effectiveness of iron therapy | The cost of iron therapy compared with the cost of epoetin | 4, 12, 24 weeks after randomization |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |