Hemodialysis ComplicationPhase 3IVO-IRONNCT04464850
Intravenous Versus Oral Iron Therapy in Hemodialysis Patients
A Phase 3 study testing Intravenous iron and Oral iron in people with Hemodialysis Complication and Anemia, run by Chiang Mai University at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Anemia, Iron Deficiency Anemia
- What is being tested?
- Intravenous iron and Oral iron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteThailand
- Study dates
- 29 Jul 2020to 31 Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University
Chiang Mai, 50200
Kajohnsak Noppakun, MD, +66815953465, kajohnsak.noppakun@cmu.ac.th
Tiranun Suriya, RN, +66818812106, tingsuri@hotmail.co.th
About this study
Official title: Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study
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
Read the 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
- Conditions
- Hemodialysis Complication, Anemia, Iron Deficiency Anemia
- Being tested
- Intravenous iron, Oral iron
- Keywords
- Iron therapy, Hemodialysis, Iron status, Epoetin dose, Intravenous iron, Oral iron
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ironDrug
Also called Venofer, Encifer
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 ironDrug
Also called Ferli-6 (ferrous fumarate 200 mg, folic acid 0.5 mg, B6 5 mg)
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
| Study group | Role | What they receive |
|---|---|---|
| Intravenous iron | Experimental | Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day Receives: Drug: Intravenous iron |
| Oral iron | Active comparator | Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day Receives: Drug: Oral iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 24 weeks after randomization
Secondary outcomes (9)
Hemoglobin levels
Levels of hemoglobin concentration
Measured: 4, 12, 24 weeks after randomization
Erythropoietin resistance index
Erythropoietin resistance index is calculated as the mean weekly epoetin dose per kg body weight divided by the average hemoglobin level
Measured: 4, 12, 24 weeks after randomization
Major cardiovascular events (MACE)
Major adverse cardiovascular events (MACE) is defined as a composite of nonfatal stroke, Nonfatal myocardial infarction, and cardiovascular death
Measured: 24-week period after randomization
Unscheduled hospitalization
Numbers of any hospitalizations that is not planned
Measured: 24-week period after randomization
Hospitalization due to infections
Numbers of any hospitalizations that is caused by infections
Measured: 24-week period after randomization
C-reactive protein (CRP)
Serum levels of high sensitivity c-reactive protein
Measured: 4, 12, 24 weeks after randomization
The kidney disease quality of life (KDQOL) instrument
Quality of life will be assessed by the kidney disease quality of life (KDQOL) instrument
Measured: 4, 12, 24 weeks after randomization
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
Measured: 4, 12, 24 weeks after randomization
Cost-effectiveness of iron therapy
The cost of iron therapy compared with the cost of epoetin
Measured: 4, 12, 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start29 Jul 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kajohnsak Noppakun, Chiang Mai University
- Investigators
- Kajohnsak Noppakun, MD, Principal investigator, Instructor, Division of Nephrology, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464850
- Sponsor's protocol ID
- MED-2563-07092
- Acronym
- IVO-IRON
- Status last verified
- Aug 2020
- First submitted
- 6 Jul 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04464850
- Acronym / sponsor ID
- IVO-IRON / MED-2563-07092
- Conditions
- Hemodialysis Complication, Anemia, Iron Deficiency Anemia
- Keywords
- Iron therapy, Hemodialysis, Iron status, Epoetin dose, Intravenous iron, Oral iron
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenous iron | Experimental | Drug: Intravenous ironIron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day |
| Oral iron | Active comparator | Drug: Oral ironFerrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous ironAlso: Venofer, EnciferIron 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 | Drug | Intravenous iron |
| Oral ironAlso: Ferli-6 (ferrous fumarate 200 mg, folic acid 0.5 mg, B6 5 mg)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 | Drug | Oral iron |
Primary outcome
Changes of epoetin dose
Time frame: 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%
9 secondary outcomes
Hemoglobin levels
Time frame: 4, 12, 24 weeks after randomization
Erythropoietin resistance index
Time frame: 4, 12, 24 weeks after randomization
Major cardiovascular events (MACE)
Time frame: 24-week period after randomization
Unscheduled hospitalization
Time frame: 24-week period after randomization
Hospitalization due to infections
Time frame: 24-week period after randomization
C-reactive protein (CRP)
Time frame: 4, 12, 24 weeks after randomization
The kidney disease quality of life (KDQOL) instrument
Time frame: 4, 12, 24 weeks after randomization
Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)
Time frame: 4, 12, 24 weeks after randomization
Cost-effectiveness of iron therapy
Time frame: 4, 12, 24 weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kajohnsak Noppakun, MD principal investigator
Instructor, Division of Nephrology, Department of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous iron and Oral iron in people with Hemodialysis Complication and Anemia, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kajohnsak Noppakun, MD (+66815953465, kajohnsak.noppakun@cmu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of epoetin dose (time frame: 24 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.