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History of Changes for Study: NCT00980681
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
Latest version (submitted April 19, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 18, 2009 None (earliest Version on record)
2 September 20, 2010 Recruitment Status, Study Status and Contacts/Locations
3 April 19, 2016 Study Status, Outcome Measures, Arms and Interventions, Sponsor/Collaborators, Study Design, Conditions, Study Description, Results, Contacts/Locations and Study Identification
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Study NCT00980681
Submitted Date:  September 18, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: DGD-44-047
Brief Title: Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
Official Title: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2009
Overall Status: Recruiting
Study Start: September 2009
Primary Completion: December 2010 [Anticipated]
Study Completion: December 2010 [Anticipated]
First Submitted: September 17, 2009
First Submitted that
Met QC Criteria:
September 18, 2009
First Posted: September 21, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 18, 2009
Last Update Posted: September 21, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Guerbet
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from renal arterial disease.
Detailed Description:
Open or close this module Conditions
Conditions: Renal Arterial Disease
Keywords: Renal artery disease
Contrast agent
MRA
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 220 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Measurement of renal artery stenosis
[ Time Frame: 0 - 28 days ]

Secondary Outcome Measures:
1. Blood sampling
[ Time Frame: 24 hours ]

2. Tolerance at the injection site
[ Time Frame: 24 hours ]

3. Adverse events
[ Time Frame: 0 - 58 days ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Anne Chibois
Telephone: 877 729 6679
Email: anne.chibois@guerbet-group.com
Locations: United States, Indiana
Guerbet LLC
[Recruiting]
Bloomington, Indiana, United States, 47403
Contact:Contact: Anne Chibois 877-729-6679 anne.chibois@guerbet-group.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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