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

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209391
First received: September 13, 2005
Last updated: October 30, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Renal Artery Stenosis
Drug: Gadodiamide Injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Subject level efficacy of CE-MRA in detecting stenosis (50% occlusion) of major renal arteries. IA-DSA is the truth standard.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 270
Study Start Date: September 2003
Detailed Description:

GEHC has decided not to provide this detail.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209391

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

No publications provided

ClinicalTrials.gov Identifier: NCT00209391     History of Changes
Other Study ID Numbers: SOV301
Study First Received: September 13, 2005
Last Updated: October 30, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Turkey: Ministry of Health
Chile: Instituto de Salud Pública de Chile
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Ministry for Health and Women
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Ministry of Health
Norway: Norwegian Medicines Agency
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Poland: Ministry of Health

Keywords provided by GE Healthcare:
Renal Artery Stenosis
Occlusion
Diagnostic Imaging
Omniscan
Magnetic Resonance Angiography
Contrast Media

Additional relevant MeSH terms:
Renal Artery Obstruction
Arterial Occlusive Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Vascular Diseases
Gadodiamide
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014