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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 (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT00980681
First received: September 17, 2009
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Condition Intervention Phase
Renal Disease
Drug: Dotarem
Other: Time of Flight
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 Magnetic Resonance Angiography (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:
  • Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ] [ Designated as safety issue: No ]
    For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared


Enrollment: 13
Study Start Date: September 2009
Study Completion Date: December 2010
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
Other Name: gadoteric acid, gadoterate meglumine
Time Of Flight
Each subject will undergo a TOF Magnetic Resonance Angiography
Other: Time of Flight
Each subject will undergo a TOF MRA

Detailed Description:
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Pierre DESCHE, MD Guerbet
  More Information

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00980681     History of Changes
Other Study ID Numbers: DGD-44-047 
Study First Received: September 17, 2009
Results First Received: July 24, 2015
Last Updated: April 19, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Guerbet:
Renal disease
Contrast agent
MRA

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 28, 2016