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

This study has been terminated.
(Lack of recruitment.)
Sponsor:
Information provided by:
Guerbet
ClinicalTrials.gov Identifier:
NCT00980681
First received: September 17, 2009
Last updated: September 20, 2010
Last verified: September 2010
History of Changes
  Purpose

The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from renal arterial disease.


Condition Intervention Phase
Renal Arterial Disease
 Drug: Dotarem
 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: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Measurement of renal artery stenosis [ Time Frame: 0 - 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood sampling [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Tolerance at the injection site [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 0 - 58 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: September 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg.
 Drug: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980681

Locations
United States, Indiana
Guerbet LLC
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Guerbet
  More Information

No publications provided

Responsible Party: Guerbet, Clinical Development
ClinicalTrials.gov Identifier: NCT00980681     History of Changes
Other Study ID Numbers: DGD-44-047
Study First Received: September 17, 2009
Last Updated: September 20, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Guerbet:
Renal artery disease
Contrast agent
MRA

ClinicalTrials.gov processed this record on May 23, 2013