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
Brief SummarySubjects 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).
PhasePhase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.
Inclusion and Exclusion 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.
- 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
- Unknown facility, Orange, California, 92660
- Unknown facility, Tucson, Arizona, 85711
- Unknown facility, Memphis, Tennessee, 38104
- Unknown facility, Madison, Wisconsin, 53705
- Unknown facility, Milwaukee, Wisconsin, 53215
- Unknown facility, Chicago, Illinois, 60611
- Unknown facility, Karlsruhe, Baden-Württemberg, 76133
- Unknown facility, Rouen Cedex, 76031
- Unknown facility, Paris Cedex 13, 75651