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

Tracking Information
First Received Date ^ICMJE	September 17, 2009
Last Updated Date	September 20, 2010
Start Date ^ICMJE	September 2009
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 18, 2009)	Measurement of renal artery stenosis [ Time Frame: 0 - 28 days ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00980681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 18, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
Official Title ^ICMJE	Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
Brief Summary	The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from renal arterial disease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Renal Arterial Disease
Intervention ^ICMJE	Drug: Dotarem Each subject will receive one injection of Dotarem 0.2ml/kg
Study Arm (s)	Experimental: Dotarem Each subject will receive one injection of Dotarem 0.2ml/kg. Intervention: Drug: Dotarem
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	220
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00980681
Other Study ID Numbers ^ICMJE	DGD-44-047
Has Data Monitoring Committee	No
Responsible Party	Guerbet, Clinical Development
Study Sponsor ^ICMJE	Guerbet
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Guerbet
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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