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

December 28, 2014 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Gadopentetate dimeglumine (Magnevist)
Approximately 0.1mmol/kg body weight, single intravenous administration on the study day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy, sensitivity and specificity based on quantitative assessment of stenosis
Time Frame: Image creation after injection - evaluation at blind read
Image creation after injection - evaluation at blind read

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient management
Time Frame: From baseline to 24 hours follow-up
From baseline to 24 hours follow-up
Safety
Time Frame: From baseline to 24 hours follow-up
From baseline to 24 hours follow-up
Diagnostic confidence
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images
Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images
Difference in degree of stenosis
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images
Other diagnostic findings
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images
Localisation matching of maximum stenosis
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images
Image quality
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images
Image evaluability and presence of artifacts
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images
Proportions of correctly categorised arteries with regard to maximum stenosis
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images
Number of evaluable arteries
Time Frame: At blinded and/or open label read of images
At blinded and/or open label read of images

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

March 31, 2006

First Submitted That Met QC Criteria

March 31, 2006

First Posted (Estimate)

April 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 28, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90940
  • 304629

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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