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Ferumoxytol for Magnetic Resonance Imaging in Patients With Severe Kidney Disease

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ClinicalTrials.gov Identifier: NCT02954510
Recruitment Status : Enrolling by invitation
First Posted : November 3, 2016
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Michael Siedlecki, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: ferumoxytol Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Intervention Model: Single Group Assignment
Intervention Model Description: case control
Masking: None (Open Label)
Masking Description: Experts evaluating ferumoxytol-enhanced magnetic resonance imaging will be masked to the results of other invasive and non-invasive cardiac testing
Primary Purpose: Diagnostic
Official Title: Ferumoxytol for Magnetic Resonance Imaging in Patients With Severe Kidney Disease
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : February 27, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Experimental: Intervention
Single arm utilizing ferumoxytol
Drug: ferumoxytol
ferumoxytol will assess patency of coronary arteries
Other Name: feraheme




Primary Outcome Measures :
  1. Detect the absence of ≥50% stenosis in the coronary artery tree [ Time Frame: 48 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


Secondary Outcome Measures :
  1. Detect stenosis in proximal and distal segments of the coronary artery tree [ Time Frame: 48 months ]
    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

  2. Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography [ Time Frame: 48 months ]
    The purpose of this secondary outcome is to determine the contrast and estimate the similarity between fcMRA, dobutamine stress echocardgiography testing with the gold standard of ICA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Both female and male participants are being studied aged 18-85 years old with an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73 meters squared. Patients will have undergone cardiac screening tests that warrant further evaluation. Patients will be excluded with an eGFR >30ml/min/1.73 meters squared.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954510


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrew Michael Siedlecki, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02954510     History of Changes
Other Study ID Numbers: 2016P000250
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the conclusion of the study de-identified data will be made available. according to guidelines described by the Biological Specimen and Data Repository Information Coordinating Center. The structure will abide by the National Heart Lung Blood Institute Policy for Data Sharing from Clinical Trials and Epidemiological Studies.
Time Frame: Within one year of the conclusion of the study. Data will be available for at least seven years.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Coronary Artery Disease
Urologic Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions