Intravenous Versus Oral Iron Therapy in Hemodialysis Patients (IVO-IRON)

Chiang Mai University

Status and phase: Unknown; Phase 3

Conditions: Iron Deficiency Anemia; Anemia; Hemodialysis Complication

Treatments: Drug: Intravenous iron; Drug: Oral iron

Study type: Interventional

Funder types: Other

Identifiers

NCT04464850

MED-2563-07092

Details and patient eligibility

About

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

Full 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

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

124 participants in 2 patient groups

Intravenous iron

Experimental group

Description:

Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day

Treatment:

Drug: Intravenous iron

Oral iron

Active Comparator group

Description:

Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day

Treatment:

Drug: Oral iron