Coronary Artery DiseasePhase 3NCT06348524
Ferumoxytol-enhanced Magnetic Resonance Imaging
A Phase 3 study testing Ferumoxytol injection in people with Coronary Artery Disease, run by Transmed Solutions.
Trial summary
There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR <30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ferumoxytol injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Dec 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic kidney disease Diagnosis of anemia of chronic kidney disease
Who cannot join
- Hypersensitivity to intravenous iron products
About this study
There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR <30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach.
Read the detailed description
This is a case control study which will assess the resolution by which the coronary arteries can be visualized using ferumoxytol-enhanced cardiac magnetic resonance angiography (fcMRA) in patients with prior regional cardiac ischemia localized by stress-induced echocardiography. Resolution will be compared to invasive coronary arteriography completed in all patients that will be analyzed at the end of the study.
Masked experts will interpret fcMRA images to determine if coronary stenosis is present or absent. By strict definitions, this is a single-arm study. However comparison will be made between fcMRA and invasive coronary arteriography performed in each patient. With a prevalence of disease of approximately 0.35 in the study population, it is anticipated that both sensitivity and specificity of fcMRA to identify the absence of coronary artery stenosis can be calculated.
- Conditions
- Coronary Artery Disease
- Being tested
- Ferumoxytol injection
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxytol injectionDrug
ferumoxytol will assess patency of coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| Single arm utilizing ferumoxytol | Experimental | Not described Receives: Drug: Ferumoxytol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the absence of ≥50% stenosis in the coronary artery tree
This outcome derives from the central hypothesis which states that coronary artery disease can more effectively be excluded in patients with severe chronic kidney disease using ferumoxtyol enhanced cardiac magnetic resonance angiography (fcMRA) rather than non-invasive cardiac testing combined with ICA. The presence or absence of a single 50% stenosis in the region of interest (measured as described above) will be dichotomized (0=absent/ 1= present) from each of the two measures, fcMRA and invasive coronary arteriography
Measured: 12 months
Secondary outcomes (2)
Detect stenosis in proximal and distal segments of the coronary artery tree
The purpose of this secondary outcome is to determine the sensitivity and specificity of fcMRA to detect the absence of lesions exhibiting ≥50% stenosis compared to ICA in proximal and distal arterial segments
Measured: 12 months
Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography
The purpose of this secondary outcome is to determine the sensitivity and specificity of fcMRA to dobutamine stress echocardgiography testing in the assessment of coronary artery stenosis when compared to ICA.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Jan 2015
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Why it stopped: new IRB not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transmed Solutions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew M Siedlecki, MD, Principal investigator, authorized representative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348524
- Sponsor's protocol ID
- ferumoxytol_2015
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ferumoxytol-enhanced Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT06348524
- Acronym / sponsor ID
- ferumoxytol_2015
- Conditions
- Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new IRB not available
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Transmed SolutionsUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 4 Apr 2024 (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.
There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR <30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach.
Detailed description
This is a case control study which will assess the resolution by which the coronary arteries can be visualized using ferumoxytol-enhanced cardiac magnetic resonance angiography (fcMRA) in patients with prior regional cardiac ischemia localized by stress-induced echocardiography. Resolution will be compared to invasive coronary arteriography completed in all patients that will be analyzed at the end of the study.
Masked experts will interpret fcMRA images to determine if coronary stenosis is present or absent. By strict definitions, this is a single-arm study. However comparison will be made between fcMRA and invasive coronary arteriography performed in each patient. With a prevalence of disease of approximately 0.35 in the study population, it is anticipated that both sensitivity and specificity of fcMRA to identify the absence of coronary artery stenosis can be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm utilizing ferumoxytol | Experimental | Drug: Ferumoxytol injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of chronic kidney disease Diagnosis of anemia of chronic kidney disease
Key exclusion criteria (1 listed)
- Hypersensitivity to intravenous iron products
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 |
|---|---|---|
| Ferumoxytol injectionferumoxytol will assess patency of coronary arteries | Drug | Single arm utilizing ferumoxytol |
Primary outcome
Detect the absence of ≥50% stenosis in the coronary artery tree
Time frame: 12 months
This outcome derives from the central hypothesis which states that coronary artery disease can more effectively be excluded in patients with severe chronic kidney disease using ferumoxtyol enhanced cardiac magnetic resonance angiography (fcMRA) rather than non-invasive cardiac testing combined with ICA. The presence or absence of a single 50% stenosis in the region of interest (measured as described above) will be dichotomized (0=absent/ 1= present) from each of the two measures, fcMRA and invasive coronary arteriography
2 secondary outcomes
Detect stenosis in proximal and distal segments of the coronary artery tree
Time frame: 12 months
Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography
Time frame: 12 months
Results and safety
The study was stopped early (reason given: new IRB not available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Andrew M Siedlecki, MD principal investigator
authorized representative
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferumoxytol injection in people with Coronary Artery Disease, run by Transmed Solutions.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: new IRB not available). Results are not available in the source record.
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?
Detect the absence of ≥50% stenosis in the coronary artery tree (time frame: 12 months). 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 7 Aug 2025.