Hemodialysis Complication, Anemia, Iron Deficiency Anemia
Conditions
Keywords
Iron therapy, Hemodialysis, Iron status, Epoetin dose, Intravenous iron, Oral iron
Brief summary
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
Detailed description
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. * Hemoglobin levels \< 6.0 g/dl * Packed red cells transfusion is required * Serum ferritin \>1,000 md/dl
Interventions
DRUGIntravenous iron
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
DRUGOral iron
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
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Hemodialysis for at least 3 months * Hemoglobin levels between 8 and 11.5 g/dl inclusive * Transferrin saturation (TSAT) \<50% and ferritin \<800 mg/dl * Stable dose of epoetin of any types and iron therapy for at least 1 month
Exclusion criteria
* History of iron allergy * Pregnant or lactating women * Patients with known hematologic disorders other than anemia of renal disease and iron deficiency anemia * Patients with hemoglobinopathy e.g., thalassemia * Patients with iron overload or hemochromatosis * Patients with gastrointestinal hemorrhage during 6 months before enrolment in to the study * Patients with current severe infection * Patients with any malignancies * Patients with severe psychiatric illness * 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 * Patients who currently receive medications that can altered gastrointestinal absorption of oral iron e.g., aluminum carbonate, aluminum hydroxide, chloramphenicol, dimercaprol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of epoetin dose | 24 weeks after randomization | 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% * 12.5 Decreased by 50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erythropoietin resistance index | 4, 12, 24 weeks after randomization | Erythropoietin resistance index is calculated as the mean weekly epoetin dose per kg body weight divided by the average hemoglobin level |
| Major cardiovascular events (MACE) | 24-week period after randomization | Major adverse cardiovascular events (MACE) is defined as a composite of nonfatal stroke, Nonfatal myocardial infarction, and cardiovascular death |
| Unscheduled hospitalization | 24-week period after randomization | Numbers of any hospitalizations that is not planned |
| Hospitalization due to infections | 24-week period after randomization | Numbers of any hospitalizations that is caused by infections |
| Hemoglobin levels | 4, 12, 24 weeks after randomization | Levels of hemoglobin concentration |
| The kidney disease quality of life (KDQOL) instrument | 4, 12, 24 weeks after randomization | Quality of life will be assessed by the kidney disease quality of life (KDQOL) instrument |
| Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels) | 4, 12, 24 weeks after randomization | 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 |
| Cost-effectiveness of iron therapy | 4, 12, 24 weeks after randomization | The cost of iron therapy compared with the cost of epoetin |
| C-reactive protein (CRP) | 4, 12, 24 weeks after randomization | Serum levels of high sensitivity c-reactive protein |
Countries
Thailand
Contacts
Primary ContactKajohnsak Noppakun, MD
Backup ContactTiranun Suriya, RN
Outcome results
None listed