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Ferumoxytol MRI for Coronary Artery Disease

Phase 3
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female and male participants aged 18-85 years old
Participants with an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73 meters squared
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial sought to compare the safety of ferumoxytol-enhanced MRI to gadolinium-based MRI in patients with an eGFR <30 mL/min.

Who is the study for?
This trial is for adults aged 18-85 with severe kidney impairment (eGFR <30ml/min/1.73m²) who need more heart tests after initial screenings. It's not for those with milder kidney issues (eGFR >30ml/min/1.73m²).Check my eligibility
What is being tested?
The study is testing ferumoxytol as a contrast agent in MRI scans for patients with coronary artery disease who can't use standard agents due to severe kidney problems.See study design
What are the potential side effects?
Ferumoxytol may cause side effects like nausea, dizziness, or skin reactions at the injection site; however, it's considered safer for kidneys than other contrast agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old.
Select...
My kidney function is low, with an eGFR under 30.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detect the absence of ≥50% stenosis in the coronary artery tree
Secondary outcome measures
Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography
Coronary artery

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Single arm utilizing ferumoxytol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ferumoxytol
2016
Completed Phase 4
~100

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,599 Previous Clinical Trials
11,462,329 Total Patients Enrolled
23 Trials studying Coronary Artery Disease
24,837 Patients Enrolled for Coronary Artery Disease

Media Library

ferumoxytol Clinical Trial Eligibility Overview. Trial Name: NCT02954510 — Phase 3
Coronary Artery Disease Research Study Groups: Intervention
Coronary Artery Disease Clinical Trial 2023: ferumoxytol Highlights & Side Effects. Trial Name: NCT02954510 — Phase 3
ferumoxytol 2023 Treatment Timeline for Medical Study. Trial Name: NCT02954510 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What additional research has been carried out on ferumoxytol?

"Currently, there are 17 different ongoing clinical trials studying ferumoxytol. 4 of those trials have progressed to Phase 3 testing. Most of the trials are being conducted in Stanford, but there are 42 different locations where patients can participate."

Answered by AI

Is this research project enrolling people who are 20 or older?

"This research project is open to individuals aged 18-85."

Answered by AI

Has ferumoxytol received clearance from the FDA?

"Ferumoxytol Phase 3 trial data looks promising, with evidence of efficacy and safety from multiple rounds of testing--giving it a safety score of 3."

Answered by AI

Which patients would best be helped by this clinical trial?

"Those who wish to partake in this coronary artery disease study must be aged between 18 and 85. A total of one hundred and eighty-five patients are needed for the trial."

Answered by AI
~23 spots leftby Mar 2025