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Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries

Primary Purpose

Renal Artery Stenosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gadopentetate dimeglumine (Magnevist)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Artery Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Has known or suspected renal artery disease - Is scheduled for X-ray angiography Exclusion Criteria: - Has any contraindication to magnetic resonance imaging - Is scheduled for any procedure before the X-ray angiography - Had previously had stents placed bilaterally in the region to be imaged

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Accuracy, sensitivity and specificity based on quantitative assessment of stenosis

    Secondary Outcome Measures

    Diagnostic confidence
    Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses
    Difference in degree of stenosis
    Other diagnostic findings
    Localisation matching of maximum stenosis
    Image quality
    Image evaluability and presence of artifacts
    Proportions of correctly categorised arteries with regard to maximum stenosis
    Number of evaluable arteries
    Patient management
    Safety

    Full Information

    First Posted
    March 31, 2006
    Last Updated
    December 28, 2014
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00310557
    Brief Title
    Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries
    Official Title
    Multicenter, Open-label Study of the Safety (Open-label) and Efficacy (Open-label and Blinded Reader) of a Single Administration of Approximately 0.1 mmol/kg of Magnevist® Injection-enhanced Magnetic Resonance Arteriography (MRA) and 2-dimensional-time-of-flight (2D-TOF) MRA in Patients With Known or Suspected Renal Artery Disease Undergoing MRA of the Renal Arteries With Intra-arterial Digital Subtraction Arteriography (i.a. DSA) as the Standard of Reference
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bayer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the renal arteries. The results will be compared to the results of MRI taken without Magnevist and with the results of your X-ray angiography.
    Detailed Description
    This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Artery Stenosis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    116 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Gadopentetate dimeglumine (Magnevist)
    Intervention Description
    Approximately 0.1mmol/kg body weight, single intravenous administration on the study day
    Primary Outcome Measure Information:
    Title
    Accuracy, sensitivity and specificity based on quantitative assessment of stenosis
    Time Frame
    Image creation after injection - evaluation at blind read
    Secondary Outcome Measure Information:
    Title
    Diagnostic confidence
    Time Frame
    At blinded and/or open label read of images
    Title
    Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses
    Time Frame
    At blinded and/or open label read of images
    Title
    Difference in degree of stenosis
    Time Frame
    At blinded and/or open label read of images
    Title
    Other diagnostic findings
    Time Frame
    At blinded and/or open label read of images
    Title
    Localisation matching of maximum stenosis
    Time Frame
    At blinded and/or open label read of images
    Title
    Image quality
    Time Frame
    At blinded and/or open label read of images
    Title
    Image evaluability and presence of artifacts
    Time Frame
    At blinded and/or open label read of images
    Title
    Proportions of correctly categorised arteries with regard to maximum stenosis
    Time Frame
    At blinded and/or open label read of images
    Title
    Number of evaluable arteries
    Time Frame
    At blinded and/or open label read of images
    Title
    Patient management
    Time Frame
    From baseline to 24 hours follow-up
    Title
    Safety
    Time Frame
    From baseline to 24 hours follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Has known or suspected renal artery disease - Is scheduled for X-ray angiography Exclusion Criteria: - Has any contraindication to magnetic resonance imaging - Is scheduled for any procedure before the X-ray angiography - Had previously had stents placed bilaterally in the region to be imaged
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bayer Study Director
    Organizational Affiliation
    Bayer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal Arteries

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