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. * Hemoglobin levels \< 6.0 g/dl * Packed red cells transfusion is required * Serum ferritin \>1,000 md/dl
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
124
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
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
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand
RECRUITINGChanges 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% * 12.5 Decreased by 50%
Time frame: 24 weeks after randomization
Hemoglobin levels
Levels of hemoglobin concentration
Time frame: 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
Time frame: 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
Time frame: 24-week period after randomization
Unscheduled hospitalization
Numbers of any hospitalizations that is not planned
Time frame: 24-week period after randomization
Hospitalization due to infections
Numbers of any hospitalizations that is caused by infections
Time frame: 24-week period after randomization
C-reactive protein (CRP)
Serum levels of high sensitivity c-reactive protein
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Time frame: 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
Time frame: 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
Time frame: 4, 12, 24 weeks after randomization
Cost-effectiveness of iron therapy
The cost of iron therapy compared with the cost of epoetin
Time frame: 4, 12, 24 weeks after randomization