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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00209391
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Gadodiamide

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209391


Locations
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Germany
Amersham Buchler GmbH & Co. KG
Ismaning, Germany
Sponsors and Collaborators
GE Healthcare
Investigators
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Study Director: Michael Karl, PhD GE Healthcare

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

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