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

Renal Artery Stenosis Clinical Trial

Official title:

Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00845702
• Other study ID #: DGD-44-046
• Status: Terminated
• Phase: Phase 3
• First received: February 16, 2009
• Last updated: April 8, 2013
• Start date: April 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2013
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Description:

Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Renal Artery Obstruction
• Renal Artery Stenosis

Intervention

Drug:
• Gadoterate meglumine (Dotarem)
Each subject will receive one injection of Dotarem 0.2 ml/kg

Other:
• Time of Flight Magnetic Resonance Angiography
Each subject will undergo a TOF MRA

Locations

Country	Name	City	State
United States	Guerbet LLC	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Non Assessable Renal Artery Segments	For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared	1 to 7 days	No