Clinical trial NCT04464850: Intravenous Versus Oral Iron Therapy in Hemodialysis Patients
Official title: Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemodialysis Complication
Anemia
Iron Deficiency Anemia
Keywords: Iron therapy
Hemodialysis
Iron status
Epoetin dose
Intravenous iron
Oral iron
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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 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

Eligibility 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

Primary outcomes:
measure: Changes of epoetin dose
timeFrame: 24 weeks after randomization
Secondary outcomes:
measure: Hemoglobin levels
timeFrame: 4, 12, 24 weeks after randomization
measure: Erythropoietin resistance index
timeFrame: 4, 12, 24 weeks after randomization
measure: Major cardiovascular events (MACE)
timeFrame: 24-week period after randomization
measure: Unscheduled hospitalization
timeFrame: 24-week period after randomization
measure: Hospitalization due to infections
timeFrame: 24-week period after randomization
measure: C-reactive protein (CRP)
timeFrame: 4, 12, 24 weeks after randomization
measure: The kidney disease quality of life (KDQOL) instrument
timeFrame: 4, 12, 24 weeks after randomization
measure: Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)
timeFrame: 4, 12, 24 weeks after randomization
measure: Cost-effectiveness of iron therapy
timeFrame: 4, 12, 24 weeks after randomization
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Instructor, Division of Nephrology, Department of Internal Medicine
name: Kajohnsak Noppakun, MD
role: PRINCIPAL_INVESTIGATOR
References: