Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study

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

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