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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Artery Stenosis
• Intervention / Treatment: Drug: Gadodiamide Injection

Detailed Description

GEHC has decided not to provide this detail.

• Study Type: Interventional
• Enrollment (Actual): 395
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Ismaning, Germany
    • Amersham Buchler GmbH & Co. KG

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Omniscan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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	72 hours

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Study Director: Michael Karl, PhD, GE Healthcare

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (Actual): August 1, 2005
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Occlusion; Contrast Media; Renal Artery Stenosis; Diagnostic Imaging; Omniscan; Magnetic Resonance Angiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Artery Obstruction
• Other Study ID Numbers: SOV301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No