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Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

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ClinicalTrials.gov Identifier: NCT00845702
Recruitment Status : Terminated (lack of recruitment.)
First Posted : February 18, 2009
Results First Posted : September 19, 2012
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Condition or disease Intervention/treatment Phase
Renal Artery Stenosis Drug: Gadoterate meglumine (Dotarem) Other: Time of Flight Magnetic Resonance Angiography Phase 3

Detailed Description:
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
Study Start Date : April 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dotarem
Each subject will receive one injection of Dotarem 0.2 ml/kg.
 Drug: Gadoterate meglumine (Dotarem)
Each subject will receive one injection of Dotarem 0.2 ml/kg
Time Of Flight Magnetic Resonance Angiography
Each subject undergo a TOF MRA
 Other: Time of Flight Magnetic Resonance Angiography
Each subject will undergo a TOF MRA


Outcome Measures
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Primary Outcome Measures :
  1. Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ]
    For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged more than 18 years,
  • Strongly suspected of having renal arterial disease,
  • Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination,

Exclusion Criteria:

  • Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²),
  • Contraindication to MRI,
  • Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination,
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00845702


Locations
United States, Indiana
Guerbet LLC
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Guerbet
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00845702     History of Changes
Other Study ID Numbers: DGD-44-046
First Posted: February 18, 2009    Key Record Dates
Results First Posted: September 19, 2012
Last Update Posted: May 20, 2016
Last Verified: April 2016

Keywords provided by Guerbet:
Renal artery stenosis
Contrast agent
MRA

Additional relevant MeSH terms:
Renal Artery Obstruction
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action