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

• ClinicalTrials.gov Identifier: NCT00980681
• Recruitment Status: Terminated
• First Posted: September 21, 2009
• Results First Posted: May 26, 2016
• Last Update Posted: May 26, 2016
• Sponsor: Guerbet
• Information provided by (Responsible Party): Guerbet

Tracking Information

• First Submitted Date: September 17, 2009
• First Posted Date: 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: September 2009
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 18, 2009): Measurement of renal artery stenosis [ Time Frame: 0 - 28 days ]
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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 Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Renal Disease

Intervention

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 19, 2016): 13
• Original Estimated Enrollment (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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00980681
• Other Study ID Numbers: DGD-44-047
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Guerbet
• Original Responsible Party: Guerbet, Clinical Development
• Current Study Sponsor: Guerbet
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pierre DESCHE, MD; Guerbet

• PRS Account: Guerbet
• Verification Date: April 2016