Intravenous Versus Oral Iron Therapy in Hemodialysis Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anemia
- Hemodialysis Complication
- Iron Deficiency Anemia
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Maintenance hemodialysis patients who are eligible to enrol into the study according to inclusion and exclusion criteria will be start with 2-week run-in period before randomization. During this run-in period, all iron supplements that patients receive including oral and intravenous iron will be discontinued.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 Sa...
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
Tracking Information
- NCT #
- NCT04464850
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Kajohnsak Noppakun, MD Instructor, Division of Nephrology, Department of Internal Medicine
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