A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide

• ClinicalTrials.gov Identifier: NCT00209391
• Recruitment Status: Completed
• First Posted: September 21, 2005
• Last Update Posted: April 25, 2019
• Sponsor: GE Healthcare
• Information provided by (Responsible Party): GE Healthcare

Study Description

Brief Summary:

Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.

Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR.

The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.

Condition or disease	Intervention/treatment	Phase
Renal Artery Stenosis	Drug: Gadodiamide Injection	Phase 3

Detailed Description:

GEHC has decided not to provide this detail.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 395 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Multicentre, Phase 3, Open-Label, Controlled Study Evaluating the Efficacy and Safety of 0.1 mmol/kg OMNISCAN (Gadodiamide Injection) in Magnetic Resonance Angiography (MRA) of the Renal Arteries
• Study Start Date: September 2003
• Actual Primary Completion Date: August 1, 2005
• Actual Study Completion Date: August 1, 2005

Arms and Interventions

Arm	Intervention/treatment
Experimental: Gadodiamide Injection; All subjects will receive a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide injection) at a dose of 0.1 mmol/kg.	Drug: Gadodiamide Injection; Other Name: Omniscan

Outcome Measures

Primary Outcome Measures :

1. Subject level efficacy of CE-MRA in detecting stenosis (50% occlusion) of major renal arteries. IA-DSA is the truth standard. [ Time Frame: 72 hours ]

Secondary Outcome Measures :

1. Subject and vessel level efficacy comparison of CE-MRA and TOF-MRA in detecting stenosis, accessing arteries and diagnosis; Efficacy of CE-MRA and TOF-MAR combined; Clinical utility; Safety [ Time Frame: 72 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Study Subjects must be adults with confirmed or suspected Renal Artery stenosis.
• The subject must have been referred for Digital Subtraction Angiography.

Exclusion Criteria:

• The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product.
• The subject is lactating.
• The subject is pregnant as defined by a serum or urine β-HCG pregnancy test obtained within 24 hours before investigational product administration.
• The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less than 24 hours after the investigational product administration.
• The subject has received or is scheduled to receive X-ray contrast medium within 7 days prior to or less than 24 hours after administration of investigational product.
• The subject has received an investigational product within 30 days prior to or will receive an investigational product less than 24 hours after investigational product administration.
• The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months.
• The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed within 4 weeks prior to investigational product administration.
• The subject has a stent in the renal arteries.
• The subject has had a kidney transplantation.
• The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L).
• The subject has previously been included in this study.
• The subject has a contra-indication for MRI according to accepted clinical guidelines.

Contacts and Locations

Locations

Germany

Amersham Buchler GmbH & Co. KG

Ismaning, Germany

Sponsors and Collaborators

GE Healthcare

Investigators

• Study Director: Michael Karl, PhD; GE Healthcare

More Information

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT00209391
• Other Study ID Numbers: SOV301
• First Posted: September 21, 2005
• Last Update Posted: April 25, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GE Healthcare:

Renal Artery Stenosis; Occlusion; Diagnostic Imaging; Omniscan; Magnetic Resonance Angiography; Contrast Media

Additional relevant MeSH terms:

Renal Artery Obstruction; Kidney Diseases; Urologic Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases