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

Tracking Information
First Submitted Date ICMJE	September 17, 2009
First Posted Date ICMJE	September 21, 2009
Results First Submitted Date	July 24, 2015
Results First Posted Date	May 26, 2016
Last Update Posted Date	May 26, 2016
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	December 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 19, 2016)	Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ]; For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Original Primary Outcome Measures ICMJE; (submitted: September 18, 2009)	Measurement of renal artery stenosis [ Time Frame: 0 - 28 days ]
Change History	Complete list of historical versions of study NCT00980681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE; (submitted: September 18, 2009)	Blood sampling [ Time Frame: 24 hours ]; Tolerance at the injection site [ Time Frame: 24 hours ]; Adverse events [ Time Frame: 0 - 58 days ]
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 Magnetic Resonance Angiography (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 compared to TOF MRA in patients suffering from renal arterial disease.
Detailed Description	Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Renal Disease
Intervention ICMJE	Drug: Dotarem Each subject will receive one injection of Dotarem 0.2ml/kg Other Name: gadoteric acid, gadoterate meglumine; Other: Time of Flight Each subject will undergo a TOF MRA
Study Arms	Experimental: Dotarem Each subject will receive one injection of Dotarem 0.2ml/kg. Intervention: Drug: Dotarem; Time Of Flight Each subject will undergo a TOF Magnetic Resonance Angiography Intervention: Other: Time of Flight
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
Actual Enrollment ICMJE; (submitted: April 19, 2016)	13
Original Estimated Enrollment ICMJE; (submitted: September 18, 2009)	220
Actual Study Completion Date	December 2010
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00980681
Other Study ID Numbers ICMJE	DGD-44-047
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Guerbet
Study Sponsor ICMJE	Guerbet
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Pierre DESCHE, MD Guerbet
PRS Account	Guerbet
Verification Date	April 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP