Gadobutrol Enhanced MRA of the Renal Arteries

NCT01344460 | Completed Phase 3 Results

• 2 other identifiers: 917592010-023002-13
• Study Type: interventional
• Target: 317
• Locations: 13 countries
• Sites: 70

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).

Conditions

Renal Artery Obstruction

Keywords

magnetic resonance angiography (MRA) of the renal arteries

Outcome Measures

Primary Outcomes (5)

• Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA

  Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant.

  Images were taken pre-injection and post-injection

• Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA

  Clinically significant disease was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.

  Images were taken pre-injection and post-injection

• Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA

  Clinically significant disease (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis.

  Images were taken pre-injection and post-injection

• Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%

  Clinically significant disease was defined as \>50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.

  Images were taken pre-injection and post-injection

• Minimum Gadobutrol Performance for Specificity: Specificity > 50%

  Clinically significant disease (stenosis) was defined as \>50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.

  Images were taken pre-injection and post-injection

Secondary Outcomes (17)

• Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader

  Images were taken pre-injection and post-injection

• Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader

  Images were taken pre-injection and post-injection

• Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images

  Images were taken pre-injection and post-injection

• 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

  Images were taken pre-injection and post-injection

• The Percentage of Segments With Artifacts Presence

  Images were taken pre-injection and post-injection

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Gadobutrol (Gadovist, BAY86-4875)

Interventions

Gadobutrol (Gadovist, BAY86-4875) DRUG

a single bolus injection of approx. 0.1mmol/kg

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (70)

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Tucson, Arizona, 85711, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90095, United States

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Orange, California, 92660, United States

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Jacksonville, Florida, 32209, United States

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Miami, Florida, 33136, United States

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Savannah, Georgia, 31406, United States

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Chicago, Illinois, 60611, United States

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Baltimore, Maryland, 21287, United States

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Durham, North Carolina, 27710, United States

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Providence, Rhode Island, 02903-4900, United States

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Memphis, Tennessee, 38104, United States

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San Antonio, Texas, 78229-3900, United States

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Madison, Wisconsin, 53705, United States

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Milwaukee, Wisconsin, 53215, United States

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Adrogué, Buenos Aires, B1846DWA, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1425BEE, Argentina

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Rosario, Santa Fe Province, S2000DTC, Argentina

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Innsbruck, Tyrol, 6020, Austria

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Vienna, 1090, Austria

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Wiener Neustadt, 2700, Austria

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Rio de Janeiro, Rio de Janeiro, 22281-100, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

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São Paulo, São Paulo, 04023-061, Brazil

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São Paulo, São Paulo, 05403-000, Brazil

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São Paulo, São Paulo, 05403-900, Brazil

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São Paulo, São Paulo, 05651-901, Brazil

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Medellín, Antioquia, Colombia

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Barranquilla, Atlántico, Colombia

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Cali, Valle del Cauca Department, Colombia

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Bogotá, Colombia

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Brno, 625 00, Czechia

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Olomouc, 775 20, Czechia

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Pilsen, 304 60, Czechia

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Prague, 12808, Czechia

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Prague, 150 30, Czechia

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La Tronche, 38700, France

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Paris, 75651, France

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Paris, 75877, France

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Paris, 75908, France

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Rouen, 76031, France

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Vandœuvre-lès-Nancy, 54500, France

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Karlsruhe, Baden-Wurttemberg, 76133, Germany

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Frankfurt am Main, Hesse, 60596, Germany

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Münster, North Rhine-Westphalia, 48145, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Lübeck, Schleswig-Holstein, 23538, Germany

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Berlin, State of Berlin, 12351, Germany

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Jena, Thuringia, 07740, Germany

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Krakow, 31-02, Poland

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Lodz, 90-153, Poland

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Lublin, 20-090, Poland

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Warsaw, 02-097, Poland

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Seoul, Seoul Teugbyeolsi, 110-744, South Korea

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Seoul, Seoul Teugbyeolsi, 135-720, South Korea

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Seoul, 135-710, South Korea

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Seoul, South Korea

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Suwon, 443-721, South Korea

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Basel, Canton of Basel-City, 4031, Switzerland

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Bern, Canton of Bern, CH-3010, Switzerland

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Olten, Canton of Solothurn, 4600, Switzerland

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Zurich, Canton of Zurich, 8091, Switzerland

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Taipei, Taipei, 116, Taiwan

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Kaoshiung, 81346, Taiwan

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Taipei, 11217, Taiwan

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Taipei, Taiwan

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Taoyuan District, 333, Taiwan

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Ankara, 06500, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Renal Artery Obstruction

Interventions

gadobutrol

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 29, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 26, 2015
• Results First Posted: August 26, 2015

Record last verified: 2015-07

Locations

US (15); CO (4); BR (6); AU (3); FR (6); AR (3); PL (4); DE (7); KR (5); TW (5); CH (4); TU (3); CZ (5)