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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310557

Enrollment

116

Registered

2006-04-04

Start date

2003-12-31

Completion date

2004-12-31

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Artery Stenosis

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.

Interventions

DRUGGadopentetate dimeglumine (Magnevist)

Approximately 0.1mmol/kg body weight, single intravenous administration on the study day

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026