Iron-Deficiency AnemiaPhase 4NCT01942460
Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients
A Phase 4 study testing Ferumoxytol in people with Iron-Deficiency Anemia and Inflammation, run by Georges Ouellet at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact of the administration of a ferumoxytol… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron-Deficiency Anemia, Inflammation, Oxidative Stress
- What is being tested?
- Ferumoxytol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Jun 2014
- Phase
- Phase 4
- 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
- For women of childbearing age, negative serum pregnancy test at screening.
- Severe chronic kidney disease (TFGe lower than 30 ml/min) OR end-stage kidney disease on peritoneal dialysis.
- Anaemia, as defined by haemoglobin (Hb) < 120 g/L, within 14 days prior to screening, in a patient with or without an Erythropoiesis-stimulating agent (ESA).
- Iron depletion, as defined by transferrin saturation (TSAT) < 20% and/or a ferritin assay (FERR) < 200, within 14 days prior to screening.
- If an ESA is used, stable dose over the past 60 days.
Who cannot join
- Allergy to ferumoxytol or another intravenous iron formulation.
- Administration of ferumoxytol or any other intravenous, intramuscular or oral iron formulation within 30 days of enrolment.
- Patient who have received a blood transfusion within 2 weeks prior to enrolment, or are planned to receive a blood transfusion over the duration of the study.
- Patient currently participating in a clinical trial with another investigational drug or device or who have received an investigational drug or device within 30 days of enrolment in this study.
- Hb < 90 g/L at the time of screening.
- Existing or clinically suspected bleeding of digestive, gynaecological or other origin.
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- Patient who have another cause of anemia, other than iron deficiency (for example, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, multiple myeloma, myelodysplastic disorder, etc.).
- Patients who are not responding to ESA or who are receiving in excess of 30000 units/week of erythropoietin (EPO), or 150 mcg/week of darbepoietin alfa.
- Major surgery within one month prior to enrolment in the study or planned surgery, other than vascular access creation, while the patient is in on the study.
- Patient who have had a malignancy (except for non-melanoma cancer of the skin) unless the patient has received curative treatment and has been disease-free for > 2 years.
- Patient who are considered by the Investigator to have a medical status that would preclude the patient's participation in this protocol.
- Patient due to have a magnetic resonance imaging examination or in whom such an examination is planned, in the next three months.
- Woman who plans to become pregnant in the next three months.
- Woman that is breastfeeding.
- Ongoing or recent (< 2 weeks) bacterial infection requiring treatment.
- Patient unable to give informed consent.
- Patient refuses to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of FERAHEME® (Ferumoxytol) for Severe Chronic Kidney Disease and Peritoneal Dialysis
The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact of the administration of a ferumoxytol dose on various markers for iron stores, as well as on various markers for inflammation and oxidative stress.
- Conditions
- Iron-Deficiency Anemia, Inflammation, Oxidative Stress
- Being tested
- Ferumoxytol
- Keywords
- Iron, Anemia, Chronic Kidney Disease, Peritoneal Dialysis, Inflammation, Oxidative stress
- Medical subject headings
- Anemia, Iron-Deficiency, Inflammation, Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
Also called Feraheme
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol | Experimental | Not described Receives: Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin, serum ferritin and transferrin saturation
Measured: 4 weeks following ferumoxytol administration
Secondary outcomes (3)
Change in inflammatory markers (C-reactive protein and Interleukin-6)
Measured: 60 minutes following ferumoxytol administration
Change in oxidative stress markers (Malondialdehyde, Advance Oxidation Protein Products, Non Transferrin-bound Iron)
Measured: 60 minutes following ferumoxytol administration
Change in soluble transferrin receptor
Measured: 4 weeks following ferumoxytol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-Deficiency AnemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georges Ouellet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Georges Ouellet, Maisonneuve-Rosemont Hospital
- Investigators
- Georges Ouellet, MD, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942460
- Sponsor's protocol ID
- FER-CA-IIT-001
- Status last verified
- Apr 2015
- First submitted
- 6 Sep 2013
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of FERAHEME® (Ferumoxytol) for Severe Chronic Kidney Disease and Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT01942460
- Acronym / sponsor ID
- FER-CA-IIT-001
- Conditions
- Iron-Deficiency Anemia, Inflammation, Oxidative Stress
- Keywords
- Iron, Anemia, Chronic Kidney Disease, Peritoneal Dialysis, Inflammation, Oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Georges OuelletUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Sep 2013 (estimated)
- 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.
The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney disease or end-stage chronic kidney disease on peritoneal dialysis, and to assess the impact of the administration of a ferumoxytol dose on various markers for iron stores, as well as on various markers for inflammation and oxidative stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferumoxytol | Experimental | Drug: Ferumoxytol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For women of childbearing age, negative serum pregnancy test at screening.
- Severe chronic kidney disease (TFGe lower than 30 ml/min) OR end-stage kidney disease on peritoneal dialysis.
- Anaemia, as defined by haemoglobin (Hb) < 120 g/L, within 14 days prior to screening, in a patient with or without an Erythropoiesis-stimulating agent (ESA).
- Iron depletion, as defined by transferrin saturation (TSAT) < 20% and/or a ferritin assay (FERR) < 200, within 14 days prior to screening.
- If an ESA is used, stable dose over the past 60 days.
Key exclusion criteria (17 listed)
- Allergy to ferumoxytol or another intravenous iron formulation.
- Administration of ferumoxytol or any other intravenous, intramuscular or oral iron formulation within 30 days of enrolment.
- Patient who have received a blood transfusion within 2 weeks prior to enrolment, or are planned to receive a blood transfusion over the duration of the study.
- Patient currently participating in a clinical trial with another investigational drug or device or who have received an investigational drug or device within 30 days of enrolment in this study.
- Hb < 90 g/L at the time of screening.
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 |
|---|---|---|
| FerumoxytolAlso: Feraheme | Drug | Ferumoxytol |
Primary outcome
Change in hemoglobin, serum ferritin and transferrin saturation
Time frame: 4 weeks following ferumoxytol administration
3 secondary outcomes
Change in inflammatory markers (C-reactive protein and Interleukin-6)
Time frame: 60 minutes following ferumoxytol administration
Change in oxidative stress markers (Malondialdehyde, Advance Oxidation Protein Products, Non Transferrin-bound Iron)
Time frame: 60 minutes following ferumoxytol administration
Change in soluble transferrin receptor
Time frame: 4 weeks following ferumoxytol administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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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.
Georges Ouellet, MD principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferumoxytol in people with Iron-Deficiency Anemia and Inflammation, run by Georges Ouellet at 1 site in Canada.
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 17 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: finished, as of the sponsor's last update on 13 Apr 2015. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin, serum ferritin and transferrin saturation (time frame: 4 weeks following ferumoxytol administration). 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 13 Apr 2015; AzTrials last refreshed its copy on 8 Nov 2026.