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Intravenous Versus Oral Iron Therapy in Hemodialysis Patients (IVO-IRON)

Primary Purpose

Hemodialysis Complication, Anemia, Iron Deficiency Anemia

Status
Unknown status
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Intravenous iron
Oral iron
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis Complication focused on measuring Iron therapy, Hemodialysis, Iron status, Epoetin dose, Intravenous iron, Oral iron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intravenous iron

Oral iron

Arm Description

Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day

Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Hemoglobin levels
Levels of hemoglobin concentration
Erythropoietin resistance index
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)
Major adverse cardiovascular events (MACE) is defined as a composite of nonfatal stroke, Nonfatal myocardial infarction, and cardiovascular death
Unscheduled hospitalization
Numbers of any hospitalizations that is not planned
Hospitalization due to infections
Numbers of any hospitalizations that is caused by infections
C-reactive protein (CRP)
Serum levels of high sensitivity c-reactive protein
The kidney disease quality of life (KDQOL) instrument
Quality of life will be assessed by the kidney disease quality of life (KDQOL) instrument
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
Cost-effectiveness of iron therapy
The cost of iron therapy compared with the cost of epoetin

Full Information

First Posted
July 6, 2020
Last Updated
August 7, 2020
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT04464850
Brief Title
Intravenous Versus Oral Iron Therapy in Hemodialysis Patients
Acronym
IVO-IRON
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Complication, Anemia, Iron Deficiency Anemia
Keywords
Iron therapy, Hemodialysis, Iron status, Epoetin dose, Intravenous iron, Oral iron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous iron
Arm Type
Experimental
Arm Description
Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day
Arm Title
Oral iron
Arm Type
Active Comparator
Arm Description
Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day
Intervention Type
Drug
Intervention Name(s)
Intravenous iron
Other Intervention Name(s)
Venofer, Encifer
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Oral iron
Other Intervention Name(s)
Ferli-6 (ferrous fumarate 200 mg, folic acid 0.5 mg, B6 5 mg)
Intervention Description
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
Primary Outcome Measure Information:
Title
Changes of epoetin dose
Description
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%
Time Frame
24 weeks after randomization
Secondary Outcome Measure Information:
Title
Hemoglobin levels
Description
Levels of hemoglobin concentration
Time Frame
4, 12, 24 weeks after randomization
Title
Erythropoietin resistance index
Description
Erythropoietin resistance index is calculated as the mean weekly epoetin dose per kg body weight divided by the average hemoglobin level
Time Frame
4, 12, 24 weeks after randomization
Title
Major cardiovascular events (MACE)
Description
Major adverse cardiovascular events (MACE) is defined as a composite of nonfatal stroke, Nonfatal myocardial infarction, and cardiovascular death
Time Frame
24-week period after randomization
Title
Unscheduled hospitalization
Description
Numbers of any hospitalizations that is not planned
Time Frame
24-week period after randomization
Title
Hospitalization due to infections
Description
Numbers of any hospitalizations that is caused by infections
Time Frame
24-week period after randomization
Title
C-reactive protein (CRP)
Description
Serum levels of high sensitivity c-reactive protein
Time Frame
4, 12, 24 weeks after randomization
Title
The kidney disease quality of life (KDQOL) instrument
Description
Quality of life will be assessed by the kidney disease quality of life (KDQOL) instrument
Time Frame
4, 12, 24 weeks after randomization
Title
Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)
Description
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
Time Frame
4, 12, 24 weeks after randomization
Title
Cost-effectiveness of iron therapy
Description
The cost of iron therapy compared with the cost of epoetin
Time Frame
4, 12, 24 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kajohnsak Noppakun, MD
Phone
+66815953465
Email
kajohnsak.noppakun@cmu.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Tiranun Suriya, RN
Phone
+66818812106
Email
tingsuri@hotmail.co.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kajohnsak Noppakun, MD
Organizational Affiliation
Instructor, Division of Nephrology, Department of Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kajohnsak Noppakun, MD
Phone
+66815953465
Email
kajohnsak.noppakun@cmu.ac.th
First Name & Middle Initial & Last Name & Degree
Tiranun Suriya, RN
Phone
+66818812106
Email
tingsuri@hotmail.co.th

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Request for individual participant data (IPD) has to be submitted to the Institutional Review Board (IRB) of Faculty of Medicine, Chiang Mai University, Chiang Mai, THAILAND.

Learn more about this trial

Intravenous Versus Oral Iron Therapy in Hemodialysis Patients

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