Gadobutrol Enhanced MRA of the Renal Arteries

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