Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

Phase 3

• Conditions: Hemodialysis Complication; Anemia; Iron Deficiency Anemia
• Interventions: Drug: Intravenous iron; Drug: Oral iron

• Registration Number: NCT04464850
• Lead Sponsor: Chiang Mai University

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

Study Timeline

• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-09
• Study Start: 2020-07-29
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11
• Primary Completion: 2021-01-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous iron	Intravenous iron	Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day
Oral iron	Oral iron	Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day

Primary Outcome Measures

Name	Time	Method
Changes of epoetin dose	24 weeks after randomization	Hemoglobin levels will be monitored and epoetin dose will be adjusted according to hemoglobin levels at 4, 12, 24 weeks after randomization.; Protocols for epoetin dose adjustments are shown as follow. Hemoglobin levels (g/dl) Epoetin dose adjustment \<9.0 Increased by 50% 9.0 to \<10.0 Increased by 25% 10.0 to \<11.5 No change 11.5 to \<12.5 Decreased by 25%; * 12.5 Decreased by 50%

Secondary Outcome Measures

Name	Time	Method
Unscheduled hospitalization	24-week period after randomization	Numbers of any hospitalizations that is not planned
C-reactive protein (CRP)	4, 12, 24 weeks after randomization	Serum levels of high sensitivity c-reactive protein
The kidney disease quality of life (KDQOL) instrument	4, 12, 24 weeks after randomization	Quality of life will be assessed by the kidney disease quality of life (KDQOL) instrument
Hospitalization due to infections	24-week period after randomization	Numbers of any hospitalizations that is caused by infections
Cost-effectiveness of iron therapy	4, 12, 24 weeks after randomization	The cost of iron therapy compared with the cost of epoetin
Erythropoietin resistance index	4, 12, 24 weeks after randomization	Erythropoietin resistance index is calculated as the mean weekly epoetin dose per kg body weight divided by the average hemoglobin level
Major cardiovascular events (MACE)	24-week period after randomization	Major adverse cardiovascular events (MACE) is defined as a composite of nonfatal stroke, Nonfatal myocardial infarction, and cardiovascular death
Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)	4, 12, 24 weeks after randomization	EQ-5D-5L is the instrument used to evaluate health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels
Hemoglobin levels	4, 12, 24 weeks after randomization	Levels of hemoglobin concentration

Trial Locations

Locations (1)

Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University; 🇹🇭 Chiang Mai, Thailand