Clinical trial NCT01344460: Gadobutrol Enhanced MRA of the Renal Arteries
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Artery Obstruction
Keywords: magnetic resonance angiography (MRA) of the renal arteries
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%
timeFrame: Images were taken pre-injection and post-injection
measure: Minimum Gadobutrol Performance for Specificity: Specificity > 50%
timeFrame: Images were taken pre-injection and post-injection
Secondary outcomes:
measure: Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader
timeFrame: Images were taken pre-injection and post-injection
measure: Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader
timeFrame: Images were taken pre-injection and post-injection
measure: Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Segments With Artifacts Presence
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA
timeFrame: Images were taken pre-injection and post-injection
measure: The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3
timeFrame: Images were taken pre-injection and post-injection
measure: Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images
timeFrame: Images were taken pre-injection and post-injection
Other outcomes:
Locations:
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state: Ciudad Auton. de Buenos Aires
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state: Tirol
city: Wiener Neustadt
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city: Wien
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state: Rio Grande do Sul
city: São Paulo
country: Brazil
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Medellín
country: Colombia
state: Antioquia
city: Barranquilla
country: Colombia
state: Atlántico
city: Cali
country: Colombia
state: Valle del Cauca
city: Bogotá
country: Colombia
city: Brno
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 5
country: Czech Republic
city: La Tronche
country: France
city: Paris Cedex 13
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city: Paris
country: France
city: Paris
country: France
city: Rouen Cedex
country: France
city: Vandoeuvre-les-nancy
country: France
city: Karlsruhe
country: Germany
state: Baden-Württemberg
city: Frankfurt
country: Germany
state: Hessen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Kiel
country: Germany
state: Schleswig-Holstein
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Jena
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
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city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
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city: Kaoshiung
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city: Taipei
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city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: