Status:
UNKNOWN
Intravenous Versus Oral Iron Therapy in Hemodialysis Patients
Lead Sponsor:
Chiang Mai University
Conditions:
Hemodialysis Complication
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04464850
Start Date
July 29 2020
End Date
July 31 2022
Last Update
August 11 2020
Active Locations (1)
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1
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand, 50200