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

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
Status
LocationsStatus
Locations

Inselspital Bern

Bern, Switzerland, CH-3010

Status
Completed
 
Locations

Universitätsspital Zürich

Zürich, Switzerland, 8091

Status
Completed
 
Locations

Kantonsspital Olten

Olten, Switzerland, 4600

Status
Completed
 
Locations

Hospital das Clínicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-900

Status
Completed
 
Locations

Klinikum der Friedrich-Schiller-Universität Jena

Jena, Germany, 07740

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60596

Status
Terminated
 
Locations

Städtisches Klinikum Karlsruhe gGmbH

Karlsruhe, Germany, 76133

Status
Terminated
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

Klinikum der Christian-Albrechts-Universität

Kiel, Germany, 24105

Status
Completed
 
Locations

SouthCoast Imaging Center

Savannah, United States, 31406

Status
Completed
 
Locations

Northwestern University Feinberg School of Medicine

Chicago, United States, 60611

Status
Completed
 
Locations

Methodist Le Bonheur Healthcare

Memphis, United States, 38104

Status
Completed
 
Locations

University of Wisconsin - Madison

Madison, United States, 53705

Status
Completed
 
Locations

University of Texas Health Science Center

San Antonio, United States, 78229-3900

Status
Completed
 
Locations

Duke University Medical Center

Durham, United States, 27710

Status
Completed
 
Locations

Rhode Island Hospital

Providence, United States, 02903-4900

Status
Completed
 
Locations

Johns Hopkins University

Baltimore, United States, 21287

Status
Completed
 
Locations

UCLA Medical Center

Los Angeles, United States, 90095

Status
Completed
 
Locations

University of Miami School of Medicine

Miami, United States, 33136

Status
Terminated
 
Locations

Hôpital Europeen Georges Pompidou

Paris, France, 75908

Status
Completed
 
Locations

CH Pitie Salpetiere, Service de Radiologie Centrale 47-83

Paris Cedex 13, France, 75651

Status
Terminated
 
Locations

Hopital Bichat - Paris

PARIS, France, 75877

Status
Completed
 
Locations

Centre Hospitalier Universitaire Brabois

VANDOEUVRE-LES-NANCY, France, 54500

Status
Terminated
 
Locations

Center Hospitalier Michallon - Grenoble

LA TRONCHE, France, 38700

Status
Completed
 
Locations

Hôpital Charles Nicolle - Rouen Cedex

ROUEN CEDEX, France, 76031

Status
Completed
 
Locations

Szpital im. N. Barlickiego

Lodz, Poland, 90-153

Status
Completed
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-090

Status
Terminated
 
Locations

Centrum Medyczne Warszawskiego Uniwersytetu Medycznego

Warszawa, Poland, 02-097

Status
Completed
 
Locations

Nemocnice na Homolce

Praha 5, Czech Republic, 150 30

Status
Terminated
 
Locations

Vseobecna fakultni nemocnice

Praha 2, Czech Republic, 12808

Status
Terminated
 
Locations

Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 775 20

Status
Completed
 
Locations

Fakultni nemocnice Plzen

Plzen, Czech Republic, 304 60

Status
Completed
 
Locations

Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Diagnóstico por Imágenes Adrogué

Adrogué, Argentina, B1846DWA

Status
Completed
 
Locations

Centro de Diagnóstico Dr. Enrique Rossi

Buenos Aires, Argentina, C1425BEE

Status
Completed
 
Locations

Diagnóstico Médico Oroño

Rosario, Argentina, S2000DTC

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Doz. Dr. Stiglbauer & Partner

Wiener Neustadt, Austria, 2700

Status
Terminated
 
Locations

Gazi Univ. Medical Faculty

Ankara, Turkey, 06500

Status
Completed
 
Locations

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey, 34098

Status
Completed
 
Locations

Istanbul Univ. Medical Faculty

Istanbul, Turkey

Status
Completed
 
Locations

Baskent University Medical Faculty

Istanbul, Turkey

Status
Completed
 
Locations

UNIFESP/EPM

Sao Paulo, Brazil, 04023-061

Status
Completed
 
Locations

Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-901

Status
Completed
 
Locations

Hospital Moinhos de Vento-Centro Clínico

Porto Alegre, Brazil, 90035-001

Status
Terminated
 
Locations

Hospital das Clínicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-000

Status
Completed
 
Locations

L'Dor - Instituto de Ensino e Pesquisa

Rio de Janeiro, Brazil, 22281-100

Status
Terminated
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Seoul Asan Medical Center

Seoul, South Korea

Status
Completed
 
Locations

Ajou University Hospital

Suwon, South Korea, 443-721

Status
Completed
 
Locations

Gangnam Severance Hospital, Yonsei University

Seoul, South Korea, 135-720

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Shing-Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan, China

Status
Completed
 
Locations

Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Terminated
 
Locations

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 333

Status
Completed
 
Locations

Wan Fang Hospital

Taipei, Taiwan, China, 116

Status
Terminated
 
Locations

Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland, 31-02

Status
Completed
 
Locations

Fundación Santa Fe de Bogotá - Hospital Universitario

Bogotá, Colombia

Status
Completed
 
Locations

Fundación Instituto de Alta tecnología médica de Antioquia

Medellín, Colombia

Status
Completed
 
Locations

DIME Clinica Neurocardiovascular S.A.

Cali, Colombia

Status
Completed
 
Locations

CENTRO DE DIAGNOSTICO MEDICO

Medellín, Colombia

Status
Terminated
 
Locations

University of Florida College of Medicine

Jacksonville, United States, 32209

Status
Completed
 
Locations

Radiology Ltd.

Tucson, United States, 85711

Status
Terminated
 
Locations

Aurora Saint Luke's Medical Center

Milwaukee, United States, 53215

Status
Completed
 
Locations

UC Irvine Medical Center

Orange, United States, 92660

Status
Terminated
 
Locations

University of Southern California

Los Angeles, United States, 90033

Status
Completed
 
Locations

Vivantes Klinikum Neukölln

Berlin, Germany, 12351

Status
Completed
 
Locations

St. Franziskus-Hospital GmbH

Münster, Germany, 48145

Status
Completed
 
Locations

Clínica de la Costa LTDA

Barranquilla, Colombia

Status
Completed
 
Locations

Veterans General Hospital

Kaoshiung, Taiwan, China, 81346

Status
Terminated
 

Trial Design