Gadobutrol Enhanced MRA of the Renal Arteries (GRAMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01344460
First received: April 5, 2011
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).


Condition Intervention Phase
Renal Artery Obstruction
Drug: Gadobutrol (Gadovist, BAY86-4875)
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: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Fraction of assessable segments [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Sensitivity for detection of clinically significant disease (50 to 99% stenosis) on a segmental basis [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Specificity for exclusion of clinically significant disease (50 to 99% stenosis) on a segmental basis [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Gadovist minimum performance criteria: Sensitivity > 50% [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Gadovist minimum performance criteria: Specificity > 50% [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Minimum diameter of the segment [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Location and length of stenotic segments with ≥ 50% stenosis [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Aneurysmal dilatation [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Artifacts by type (segmental) [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Diagnostic confidence (segmental) [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]
  • Additional imaging studies recommended (example: non contrast MRA, contrast enhanced MRA, computed tomography angiography, Ultrasound, Nuclear medicine study) [ Time Frame: At approximately 15 months after last patient last visit. ] [ Designated as safety issue: No ]

    What additional imaging studies would be necessary is a measure of 1) what test provides a definitive diagnosis for treatment decisions and 2) is a direct measure of additional cost a health system would incur for additional imaging studies to reach a definitive diagnosis. This is critical to determining the total cost of imaging for a patient diagnosis in any health system reimbursement structure.

    Therefore the social/societal cost for not providing a definitive diagnosis with a single imaging study can be determined for health policy and reimbursement decisions.



Enrollment: 315
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
a single bolus injection of approx. 0.1mmol/kg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, aged ≥ 18 years
  • Known or suspected renal artery disease based on any of the following:

    • Referred for evaluation of the renal arteries for clinically significant stenosis
    • Follow-up for a metallic stent in a renal artery
    • Prior imaging study (CTA) showing ≥ 50% renal artery stenosis (within 60 days prior to consent)
  • Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography (CE MRA) examinations with gadobutrol.
  • Willingness and ability to follow directions and complete all study procedures specified in the protocol.
  • Females of childbearing potential only: Negative pregnancy test on the day of the MRA prior to administration of study drug.
  • Written informed consent (IC), including information about the provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable.

Exclusion Criteria:

  • Pregnant or nursing (including pumping for storage and feeding)
  • Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study
  • Previous enrolment into this study or into any other Bayer sponsored study using gadobutrol
  • Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI)
  • Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nefrogenic Systemic Fibrosis (NSF)
  • History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
  • Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.)
  • Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.)
  • Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
  • Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
  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: NCT01344460

  Show 70 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01344460     History of Changes
Other Study ID Numbers: 91759, 2010-023002-13
Study First Received: April 5, 2011
Last Updated: July 28, 2014
Health Authority: Argentina: Ministry of Health
Austria: Federal Office for Safety in Health Care
Brazil: Ministry of Health
China: Food and Drug Administration
Colombia: National Institute of Health
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Korea: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Switzerland: Swissmedic
Taiwan: Department of Health
Turkey: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Bayer:
magnetic resonance angiography (MRA) of the renal arteries

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

ClinicalTrials.gov processed this record on August 28, 2014