NCT06348524

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_3 coronary-artery-disease

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_3 coronary-artery-disease

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
Last Updated

August 7, 2025

Status Verified

August 1, 2025

Enrollment Period

8 years

First QC Date

July 29, 2023

Last Update Submit

August 1, 2025

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (2)

  • Detect stenosis in proximal and distal segments of the coronary artery tree

    12 months

  • Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography

    12 months

Study Arms (1)

Single arm utilizing ferumoxytol

EXPERIMENTAL
Drug: Ferumoxytol injection

Interventions

Ferumoxytol injectionDRUG

ferumoxytol will assess patency of coronary arteries

Single arm utilizing ferumoxytol

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic kidney disease Diagnosis of anemia of chronic kidney disease

You may not qualify if:

  • Hypersensitivity to intravenous iron products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsFerrous CompoundsMinerals

Study Officials

  • Andrew M Siedlecki, MD

    authorized representative

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2023

First Posted

April 4, 2024

Study Start

January 1, 2015

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

August 7, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share