Contrast-Enhanced MRI of the renal arteries

Conditions: Subjects with known or suspected renal artery disease
MedDRA version: 14.1Level: PTClassification code 10038378Term: Renal artery stenosisSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2010-023002-13-DE

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 336

Inclusion Criteria

The following inclusion criteria must be met at the time of screening unless otherwise specified.

1. Male or female subjects, aged = 18 years
2. Known or suspected renal artery disease based on any of the following:
a. Referred for evaluation of the renal arteries for clinically significant stenosis. In Germany, only subjects who undergo a CTA within 60 days prior to consent or subjects who clinically require a CTA which is ordered by the referring physician as part of the standard clinical routine will be included. Once the German Radiation Protection Authority has approved the conduct of a study-specific CTA, subjects without prior CTA or referral for a clinically indicated CTA can be included and undergo a CTA as part of the study.
b. follow-up for a metallic stent in a renal artery
c. prior imaging study (CTA) showing = 50% renal artery stenosis (within 60 days prior to consent)
If there is inadequate enrollment of subjects with clinically significant disease (based on CTA interpretation made by the investigators) then the enrollment may be restricted to subjects who underwent a CTA (within 60 days prior to consent) or clinically indicated and ordered by the referring physician as part of the standard clinical routine (within 7 days prior to the MRA) showing at least moderate disease (= 50%). Once the German Radiation Protection Authority has approved the conduct of a study-specific CTA, subjects without prior CTA or referral for clinically indicated CTA can be included and undergo a CTA as part of the study. This would meet the protocol guidelines as described in Section 8.6.2.

Note: Any CTA must meet the specifications provided in Section 7.3.4 and will be used as the SoR for this study. If the CTA does not meet the specifications, then the CTA has to be repeated as part of the study or the subject cannot be enrolled.

3. Willingness to undergo the routine CE MRA examinations with gadobutrol
4. Willingness and ability to follow directions and complete all study procedures specified in the protocol
5. Females of childbearing potential only: Negative pregnancy test on the day of the MRA prior to administration of study drug
6. Written informed consent, including information about the provisions of the Health Insurance Portability and Accountability Act as applicable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following criteria at the time of screening will be excluded:

1. Pregnant or nursing (including pumping for storage and feeding)
2. Received any other investigational product or participation in any other clinical trial within 30 days prior to enrollment in this study
3. Previous enrollment into this study or any other Bayer sponsored study using gadobutrol
4. Contraindication to the MRI examination (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators, or other metallic devices not approved for MRI)
5. Contraindications to the use of Gd-containing contrast agents (including subjects who are suspected for or known to have NSF)
6. History of severe (as judged by the investigator, taking into account the intensity of the event) allergic or anaphylactoid reaction to any allergen including drugs and contrast agents
7. Received any contrast agent within 72 hours prior to the study MRA, or is scheduled to receive any contrast agent within 72 hours after the study MRA
(Note: This applies also to a CTA potentially scheduled during the course of the study)
8. Estimated glomerular filtration rate (eGFR) value < 30 mL/min/1.73 m² derived from a serum creatinine result within 2 weeks prior to gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from enrollment.
(Note: If there are multiple creatinine values, the values obtained prior to and closest to the time of the MRA should be used. The core lab value should not be used if not available prior to the MRA/CTA).
9. Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the perioperative liver transplantation period.
10. Known history of 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
11. Suspected clinical instability or unpredictability of the clinical course during the study period (e.g., due to previous surgery or acute stroke)
12. Scheduled or potentially expected for the period between the CTA and gadobutrol MRA:
a. any procedure that may alter the MRA or CTA interpretation, or
b. any interventional or surgical procedure involving the renal or abdominal aorta