Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

Anemia Clinical Trial

— IVO-IRON  

Official title:

Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464850
• Other study ID #: MED-2563-07092
• Status: Recruiting
• Phase: Phase 3
• Start date: July 29, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2020
• Source: Chiang Mai University
• Contact: Kajohnsak Noppakun, MD
• Phone: +66815953465
• Email: kajohnsak.noppakun[@]cmu.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: July 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Hemodialysis Complication
• Iron Deficiency Anemia

Intervention

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
• 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

Locations

Country	Name	City	State
Thailand	Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of epoetin dose	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%	24 weeks after randomization
Secondary	Hemoglobin levels	Levels of hemoglobin concentration	4, 12, 24 weeks after randomization
Secondary	Erythropoietin resistance index	Erythropoietin resistance index is calculated as the mean weekly epoetin dose per kg body weight divided by the average hemoglobin level	4, 12, 24 weeks after randomization
Secondary	Major cardiovascular events (MACE)	Major adverse cardiovascular events (MACE) is defined as a composite of nonfatal stroke, Nonfatal myocardial infarction, and cardiovascular death	24-week period after randomization
Secondary	Unscheduled hospitalization	Numbers of any hospitalizations that is not planned	24-week period after randomization
Secondary	Hospitalization due to infections	Numbers of any hospitalizations that is caused by infections	24-week period after randomization
Secondary	C-reactive protein (CRP)	Serum levels of high sensitivity c-reactive protein	4, 12, 24 weeks after randomization
Secondary	The kidney disease quality of life (KDQOL) instrument	Quality of life will be assessed by the kidney disease quality of life (KDQOL) instrument	4, 12, 24 weeks after randomization
Secondary	Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)	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	4, 12, 24 weeks after randomization
Secondary	Cost-effectiveness of iron therapy	The cost of iron therapy compared with the cost of epoetin	4, 12, 24 weeks after randomization