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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00310557
First received: March 31, 2006
Last updated: July 6, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Renal Artery Stenosis
 Drug: Gadopentetate dimeglumine (Magnevist)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • Diagnostic confidence [ Time Frame: 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 ]
  • Difference in degree of stenosis [ Time Frame: At blinded and/or open label read of images ]
  • Other diagnostic findings [ Time Frame: 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 ]
  • Image quality [ Time Frame: 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 ]
  • Proportions of correctly categorised arteries with regard to maximum stenosis [ Time Frame: At blinded and/or open label read of images ]
  • Number of evaluable arteries [ Time Frame: At blinded and/or open label read of images ]
  • Patient management [ Time Frame: From baseline to 24 hours follow-up ]
  • Safety [ Time Frame: From baseline to 24 hours follow-up ]

Enrollment: 118
Study Start Date: December 2003
Study Completion Date: December 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadopentetate dimeglumine (Magnevist)
Approximately 0.1mmol/kg body weight, single intravenous administration on the study day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310557

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00310557     History of Changes
Other Study ID Numbers: 90940, 304629
Study First Received: March 31, 2006
Last Updated: July 6, 2009
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Chile: Ministry of Health

Additional relevant MeSH terms:
Constriction, Pathologic
Renal Artery Obstruction
Pathological Conditions, Anatomical
Kidney Diseases
 Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013