check_circleStudy Completed

Contrast media

Bayer Identifier:

13701

ClinicalTrials.gov Identifier:

NCT00908596

EudraCT Number:

2008-005867-33

EU CT Number:

Not Available
Primovist / Eovist in Renally Impaired patients

Trial purpose

Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.
The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist.
Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

Key Participants Requirements

Sex

Both

Age

18 - N/A

  • - Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
    - Patient must fulfill criteria for moderate (Estimated glomerular filtration rate [eGFR] 30 - 59 mL/min/1.73 m^2) to severe (eGFR < 30 mL/min/1.73 m^2) renal impairment.

  • - Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
    - History of existing NSF

Trial summary

Enrollment Goal
357
Trial Dates
May 2009 - July 2013
Phase
Phase 4
Could I Receive a placebo
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
St.-Johannes-Hospital DortmundDortmund, 44137, Germany
Completed
Southmead HospitalBristol, BS10 5NB, United Kingdom
Completed
University of MichiganAnn Arbor, 48109, United States
Completed
Johns Hopkins UniversityBaltimore, 21287, United States
Completed
Methodist Le Bonheur HealthcareMemphis, 38104, United States
Completed
Weill Cornell Medical CollegeNew York, 10021, United States
Completed
A.O. Spedali Civili di BresciaBrescia, 25123, Italy
Completed
IRCCS INT Fondazione PascaleNapoli, 80131, Italy
Terminated
IRCCS Fondazione del Piemonte per l'OncologiaCandiolo, 10060, Italy
Completed
ISMETT Ist Mediterraneo Trapianti e Terapie ad alta specialPalermo, 90127, Italy
Completed
IRCCS Istituto Europeo Oncologia - IEOMilano, 20141, Italy
Completed
Westmead HospitalWestmead NSW, 2145, Australia
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Pusan National UniversityBusan, 602-739, Korea, Republic Of
Completed
Kangnam St.Marry’s HospitalSeoul, Korea, Republic Of
Completed
Siriraj Hospital, MahidolBangkok, 10700, Thailand
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
SRH Wald-Klinikum Gera gGmbHGera, 07548, Germany
Completed
Otto-von-Guericke-Universität MagdeburgMagdeburg, 39120, Germany
Terminated
Universitätsklinikum EssenEssen, 45122, Germany
Terminated
Universitätsklinikum ErlangenErlangen, 91054, Germany
Completed
Robert-Bosch-KrankenhausStuttgart, 70376, Germany
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Terminated
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Universitätsklinik Gießen und Marburg GmbHMarburg, 35033, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60596, Germany
Terminated
Precise Clinical Research Solutions/ Midwest RadiologyTopeka, 66604, United States
Completed
University of Florida College of MedicineJacksonville, 32209, United States
Terminated
Maimonides Medical CenterBrooklyn, 11219, United States
Terminated
University of Southern California-University HospitalLos Angeles, 90033, United States
Terminated
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Completed
University of Texas Health Science CenterSan Antonio, 78229, United States
Completed
Duke University Medical CenterDurham, 27710, United States
Terminated
Straub Clinic & HospitalHonolulu, 96813, United States
Completed
A.O.U. PisanaPisa, 56124, Italy
Terminated
ASL NA/2 Pozzuoli - CampaniaPozzuoli, 80078, Italy
Completed
IRCCS Istituto Clinico HumanitasRozzano, 20089, Italy
Completed
Hospital Clínico Universitario San CecilioGranada, 18012, Spain
Terminated
Geelong HospitalGeelong, 3220, Australia
Completed
Royal Adelaide HospitalAdelaide, 5000, Australia
Completed
Royal Brisbane & Women's HospitalHerston, 4029, Australia
Terminated
Princess Alexandra HospitalWoollongabba, 4102, Australia
Completed
Seoul Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Seoul Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Prince of Songkla UniversitySongkhla, 90110, Thailand
Completed
Ramathibodhi HospitalBangkok, Thailand

Primary Outcome

  • Number of participants with moderate to severe renal impairment, who develop NSF (Nephrogenic systemic fibrosis), based on diagnostically specific clinical and histopathological information
    date_rangeTime Frame:
    Up to 24 months following the administration of Primovist/Eovist
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of participants with moderate to severe renal impairment in whom no biopsy was obtained who develop NSF-like symptoms based on diagnostically specific clinical information summarized by clinical score
    date_rangeTime Frame:
    Up to 24 months following the administration of Primovist/Eovist
    enhanced_encryption
    Safety Issue:
    Yes
  • Confidence of the investigator to make a diagnosis based on the Primovist/Eovist enhanced MRI (Magnetic resonance imaging)
    date_rangeTime Frame:
    Immediately after Primovist/Eovist-enhanced MRI
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with “Excellent / Good / Adequate / Insufficient” scores for lesion detection
    date_rangeTime Frame:
    Immediately after Primovist/Eovist-enhanced MRI
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with “Excellent / Good / Adequate / Insufficient” scores for lesion delineation
    date_rangeTime Frame:
    Immediately after Primovist/Eovist-enhanced MRI
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with “Excellent / Good / Adequate / Insufficient” scores for lesion characterization
    date_rangeTime Frame:
    Immediately after Primovist/Eovist-enhanced MRI
    enhanced_encryption
    Safety Issue:
    No

Trial design

Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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