Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiang Mai University
• Treatments: Ferrous fumarate; Folic Acid; Iron

Criteria

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