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
  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:


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 April 21, 2014