Trial Condition(s):

Renal artery obstruction

Gadobutrol enhanced MRA of the renal arteries (GRAMS)

Bayer Identifier:

91759

ClinicalTrials.gov Identifier:

NCT01344460

EudraCT Number:

2010-023002-13

EU CT Number:

Not Available

Study Completed

Trial Purpose

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).

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

Trial Summary

Enrollment Goal
317
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Inselspital Bern

Bern, Switzerland, CH-3010

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Universitätsspital Zürich

Zürich, Switzerland, 8091

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Kantonsspital Olten

Olten, Switzerland, 4600

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Hospital das Clínicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-900

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Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07740

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Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60596

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Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Germany, 76133

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Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

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Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

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SouthCoast Imaging Center

Savannah, United States, 31406

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Northwestern University Feinberg School of Medicine

Chicago, United States, 60611

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Methodist Le Bonheur Healthcare

Memphis, United States, 38104

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University of Wisconsin - Madison

Madison, United States, 53705

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University of Texas Health Science Center

San Antonio, United States, 78229-3900

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Duke University Medical Center

Durham, United States, 27710

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Rhode Island Hospital

Providence, United States, 02903-4900

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Johns Hopkins University

Baltimore, United States, 21287

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UCLA Medical Center

Los Angeles, United States, 90095

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University of Miami School of Medicine

Miami, United States, 33136

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Hôpital Europeen Georges Pompidou

Paris, France, 75908

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CH Pitie Salpetiere, Service de Radiologie Centrale 47-83

Paris Cedex 13, France, 75651

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Hopital Bichat - Paris

PARIS, France, 75877

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Centre Hospitalier Universitaire Brabois

VANDOEUVRE-LES-NANCY, France, 54500

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Center Hospitalier Michallon - Grenoble

LA TRONCHE, France, 38700

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Hôpital Charles Nicolle - Rouen Cedex

ROUEN CEDEX, France, 76031

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Szpital im. N. Barlickiego

Lodz, Poland, 90-153

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Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-090

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Centrum Medyczne Warszawskiego Uniwersytetu Medycznego

Warszawa, Poland, 02-097

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Nemocnice na Homolce

Praha 5, Czech Republic, 150 30

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Vseobecna fakultni nemocnice

Praha 2, Czech Republic, 12808

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Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 775 20

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Fakultni nemocnice Plzen

Plzen, Czech Republic, 304 60

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Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

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Diagnóstico por Imágenes Adrogué

Adrogué, Argentina, B1846DWA

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Centro de Diagnóstico Dr. Enrique Rossi

Buenos Aires, Argentina, C1425BEE

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Diagnóstico Médico Oroño

Rosario, Argentina, S2000DTC

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Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

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Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

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Doz. Dr. Stiglbauer & Partner

Wiener Neustadt, Austria, 2700

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Gazi Univ. Medical Faculty

Ankara, Turkey, 06500

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Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey, 34098

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Istanbul Univ. Medical Faculty

Istanbul, Turkey

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Baskent University Medical Faculty

Istanbul, Turkey

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UNIFESP/EPM

Sao Paulo, Brazil, 04023-061

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Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-901

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Hospital Moinhos de Vento-Centro Clínico

Porto Alegre, Brazil, 90035-001

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Hospital das Clínicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-000

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L'Dor - Instituto de Ensino e Pesquisa

Rio de Janeiro, Brazil, 22281-100

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Seoul National University Hospital

Seoul, South Korea, 110-744

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Seoul Asan Medical Center

Seoul, South Korea

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Ajou University Hospital

Suwon, South Korea, 443-721

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Gangnam Severance Hospital, Yonsei University

Seoul, South Korea, 135-720

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Samsung Medical Center

Seoul, South Korea, 135-710

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Universitätsspital Basel

Basel, Switzerland, 4031

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Shing-Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan, China

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Veterans General Hospital

Taipei, Taiwan, China, 11217

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Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 333

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Wan Fang Hospital

Taipei, Taiwan, China, 116

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Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland, 31-02

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Fundación Santa Fe de Bogotá - Hospital Universitario

Bogotá, Colombia

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Fundación Instituto de Alta tecnología médica de Antioquia

Medellín, Colombia

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DIME Clinica Neurocardiovascular S.A.

Cali, Colombia

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CENTRO DE DIAGNOSTICO MEDICO

Medellín, Colombia

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University of Florida College of Medicine

Jacksonville, United States, 32209

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Radiology Ltd.

Tucson, United States, 85711

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Aurora Saint Luke's Medical Center

Milwaukee, United States, 53215

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UC Irvine Medical Center

Orange, United States, 92660

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University of Southern California

Los Angeles, United States, 90033

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Vivantes Klinikum Neukölln

Berlin, Germany, 12351

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St. Franziskus-Hospital GmbH

Münster, Germany, 48145

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Clínica de la Costa LTDA

Barranquilla, Colombia

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Veterans General Hospital

Kaoshiung, Taiwan, China, 81346

Trial Design