check_circleStudy Completed

Renal artery obstruction

Bayer Identifier:

91759

ClinicalTrials.gov Identifier:

NCT01344460

EudraCT Number:

2010-023002-13

EU CT Number:

Not Available
Gadobutrol enhanced MRA of the renal arteries

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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.
  • - 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
May 2011 - July 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Inselspital BernBern, CH-3010, Switzerland
Completed
Universitätsspital ZürichZürich, 8091, Switzerland
Completed
Kantonsspital OltenOlten, 4600, Switzerland
Completed
Hospital das Clínicas da Faculdade de Medicina da USPSao Paulo, 05403-900, Brazil
Completed
Klinikum der Friedrich-Schiller-Universität JenaJena, 07740, Germany
Terminated
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60596, Germany
Terminated
Städtisches Klinikum Karlsruhe gGmbHKarlsruhe, 76133, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Completed
SouthCoast Imaging CenterSavannah, 31406, United States
Completed
Northwestern University Feinberg School of MedicineChicago, 60611, United States
Completed
Methodist Le Bonheur HealthcareMemphis, 38104, United States
Completed
University of Wisconsin - MadisonMadison, 53705, United States
Completed
University of Texas Health Science CenterSan Antonio, 78229-3900, United States
Completed
Duke University Medical CenterDurham, 27710, United States
Completed
Rhode Island HospitalProvidence, 02903-4900, United States
Completed
Johns Hopkins UniversityBaltimore, 21287, United States
Completed
UCLA Medical CenterLos Angeles, 90095, United States
Terminated
University of Miami School of MedicineMiami, 33136, United States
Completed
Hôpital Europeen Georges PompidouParis, 75908, France
Terminated
CH Pitie Salpetiere, Service de Radiologie Centrale 47-83Paris Cedex 13, 75651, France
Completed
Hopital Bichat - ParisPARIS, 75877, France
Terminated
Centre Hospitalier Universitaire BraboisVANDOEUVRE-LES-NANCY, 54500, France
Completed
Center Hospitalier Michallon - GrenobleLA TRONCHE, 38700, France
Completed
Hôpital Charles Nicolle - Rouen CedexROUEN CEDEX, 76031, France
Completed
Szpital im. N. BarlickiegoLodz, 90-153, Poland
Terminated
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20-090, Poland
Completed
Centrum Medyczne Warszawskiego Uniwersytetu MedycznegoWarszawa, 02-097, Poland
Terminated
Nemocnice na HomolcePraha 5, 150 30, Czech Republic
Terminated
Vseobecna fakultni nemocnicePraha 2, 12808, Czech Republic
Completed
Fakultni Nemocnice OlomoucOlomouc, 775 20, Czech Republic
Completed
Fakultni nemocnice PlzenPlzen, 304 60, Czech Republic
Completed
Fakultni nemocnice BrnoBrno, 625 00, Czech Republic
Completed
Diagnóstico por Imágenes AdroguéAdrogué, B1846DWA, Argentina
Completed
Centro de Diagnóstico Dr. Enrique RossiBuenos Aires, C1425BEE, Argentina
Completed
Diagnóstico Médico OroñoRosario, S2000DTC, Argentina
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Terminated
Doz. Dr. Stiglbauer & PartnerWiener Neustadt, 2700, Austria
Completed
Gazi Univ. Medical FacultyAnkara, 06500, Turkey
Completed
Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, 34098, Turkey
Completed
Istanbul Univ. Medical FacultyIstanbul, Turkey
Completed
Baskent University Medical FacultyIstanbul, Turkey
Completed
UNIFESP/EPMSao Paulo, 04023-061, Brazil
Completed
Hospital Israelita Albert EinsteinSão Paulo, 05651-901, Brazil
Terminated
Hospital Moinhos de Vento-Centro ClínicoPorto Alegre, 90035-001, Brazil
Completed
Hospital das Clínicas da Faculdade de Medicina da USPSao Paulo, 05403-000, Brazil
Terminated
L'Dor - Instituto de Ensino e PesquisaRio de Janeiro, 22281-100, Brazil
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Seoul Asan Medical CenterSeoul, Korea, Republic Of
Completed
Ajou University HospitalSuwon, 443-721, Korea, Republic Of
Completed
Gangnam Severance Hospital, Yonsei UniversitySeoul, 135-720, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Shing-Kong Wu Ho-Su Memorial HospitalTaipei, Taiwan
Terminated
Veterans General HospitalTaipei, 11217, Taiwan
Completed
Chang Gung Memorial Hospital at LinkouTaoyuan, 333, Taiwan
Terminated
Wan Fang HospitalTaipei, 116, Taiwan
Completed
Szpital Specjalistyczny im. Jana Pawla IIKrakow, 31-02, Poland
Completed
Fundación Santa Fe de Bogotá - Hospital UniversitarioBogotá, Colombia
Completed
Fundación Instituto de Alta tecnología médica de AntioquiaMedellín, Colombia
Completed
DIME Clinica Neurocardiovascular S.A.Cali, Colombia
Terminated
CENTRO DE DIAGNOSTICO MEDICOMedellín, Colombia
Completed
University of Florida College of MedicineJacksonville, 32209, United States
Terminated
Radiology Ltd.Tucson, 85711, United States
Completed
Aurora Saint Luke's Medical CenterMilwaukee, 53215, United States
Terminated
UC Irvine Medical CenterOrange, 92660, United States
Completed
University of Southern CaliforniaLos Angeles, 90033, United States
Completed
Vivantes Klinikum NeuköllnBerlin, 12351, Germany
Completed
St. Franziskus-Hospital GmbHMünster, 48145, Germany
Completed
Clínica de la Costa LTDABarranquilla, Colombia
Terminated
Veterans General HospitalKaoshiung, 81346, Taiwan

Primary Outcome

  • Fraction of assessable segments
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity for detection of clinically significant disease (50 to 99% stenosis) on a segmental basis
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Specificity for exclusion of clinically significant disease (50 to 99% stenosis) on a segmental basis
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Gadovist minimum performance criteria: Sensitivity > 50%
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Gadovist minimum performance criteria: Specificity > 50%
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Minimum diameter of the segment
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Location and length of stenotic segments with ≥ 50% stenosis
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Aneurysmal dilatation
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Artifacts by type (segmental)
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Diagnostic confidence (segmental)
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No
  • Additional imaging studies recommended (example: non contrast MRA, contrast enhanced MRA, computed tomography angiography, Ultrasound, Nuclear medicine study)
    What additional imaging studies would be necessary is a measure of 1) what test provides a definitive diagnosis for treatment decisions and 2) is a direct measure of additional cost a health system would incur for additional imaging studies to reach a definitive diagnosis. This is critical to determining the total cost of imaging for a patient diagnosis in any health system reimbursement structure. Therefore the social/societal cost for not providing a definitive diagnosis with a single imaging study can be determined for health policy and reimbursement decisions.
    date_rangeTime Frame:
    At approximately 15 months after last patient last visit.
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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