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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

September 17, 2009
September 20, 2010
September 2009
December 2010   (final data collection date for primary outcome measure)
Measurement of renal artery stenosis [ Time Frame: 0 - 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00980681 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Renal Arterial Disease
Drug: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg
Experimental: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg.
Intervention: Drug: Dotarem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
220
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00980681
DGD-44-047
No
Guerbet, Clinical Development
Guerbet
Not Provided
Not Provided
Guerbet
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP