NCT04464850

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Chiang Mai University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hemodialysis Complication
• Anemia
• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Intravenous 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
DRUG	Oral 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

Timeline

• Start date: 2020-07-29
• Primary completion: 2021-01-31
• Completion: 2022-07-31
• First posted: 2020-07-09
• Last updated: 2020-08-11

Locations

1 site across 1 country: Thailand