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

Phase 3

Terminated

• Conditions: Renal Artery Stenosis
• Interventions: Other: Time of Flight Magnetic Resonance Angiography; Drug: Gadoterate meglumine (Dotarem)

• Registration Number: NCT00845702
• Lead Sponsor: Guerbet

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 Timeline

• Study First Submitted: 2009-02-16
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Study Start: 2009-04
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Results First Submitted: 2011-09-22
• Results First Submitted QC: 2012-09-18
• Results First Posted: 2012-09-19
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Time Of Flight Magnetic Resonance Angiography	Time of Flight Magnetic Resonance Angiography	Each subject undergo a TOF MRA
Dotarem	Gadoterate meglumine (Dotarem)	Each subject will receive one injection of Dotarem 0.2 ml/kg.

Primary Outcome Measures

Name	Time	Method
Percent of Non Assessable Renal Artery Segments	1 to 7 days	For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared

Trial Locations

Locations (1)

Guerbet LLC; 🇺🇸 Bloomington, Indiana, United States