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

NCT00980681 | Terminated Phase 3 Results

• 1 other identifier: DGD-44-047
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Disease

Keywords

Renal disease; Contrast agent; MRA

Outcome Measures

Primary Outcomes (1)

• Percent of Non Assessable Renal Artery Segments

  For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared

  1 to 7 days

Study Arms (2)

Dotarem

EXPERIMENTAL

Each subject will receive one injection of Dotarem 0.2ml/kg.

Drug: Dotarem

Time Of Flight

OTHER

Each subject will undergo a TOF Magnetic Resonance Angiography

Other: Time of Flight

Interventions

Dotarem DRUG

Each subject will receive one injection of Dotarem 0.2ml/kg

Also known as: gadoteric acid, gadoterate meglumine

Dotarem

Time of Flight OTHER

Each subject will undergo a TOF MRA

Time Of Flight

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guerbet: lead

Study Sites (1)

Guerbet LLC

Bloomington, Indiana, 47403, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

The study was not completed due to poor enrolment. The statistical analysis was not perfomed.

Results Point of Contact

• Title: Pierre Desche, MD, Head of Clinical and Regulatory Affairs
• Organization: Guerbet

pierre.desche@guerbet-group.com

+33 1 45 91 50 00

Study Officials

• Pierre DESCHE, MD

  Guerbet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 21, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 26, 2016
• Results First Posted: May 26, 2016

Record last verified: 2016-04

Locations

US (1)