We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00310557
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Renal Artery Stenosis Drug: Gadopentetate dimeglumine (Magnevist) Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2003
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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

Secondary Outcome Measures :
  1. Diagnostic confidence [ Time Frame: At blinded and/or open label read of images ]
  2. Accuracy, sensitivity, and specificity based on visual assessment of stenosis assesses [ Time Frame: At blinded and/or open label read of images ]
  3. Difference in degree of stenosis [ Time Frame: At blinded and/or open label read of images ]
  4. Other diagnostic findings [ Time Frame: At blinded and/or open label read of images ]
  5. Localisation matching of maximum stenosis [ Time Frame: At blinded and/or open label read of images ]
  6. Image quality [ Time Frame: At blinded and/or open label read of images ]
  7. Image evaluability and presence of artifacts [ Time Frame: At blinded and/or open label read of images ]
  8. Proportions of correctly categorised arteries with regard to maximum stenosis [ Time Frame: At blinded and/or open label read of images ]
  9. Number of evaluable arteries [ Time Frame: At blinded and/or open label read of images ]
  10. Patient management [ Time Frame: From baseline to 24 hours follow-up ]
  11. Safety [ Time Frame: From baseline to 24 hours follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00310557


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00310557     History of Changes
Other Study ID Numbers: 90940
304629
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

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