Trial Condition(s):

Contrast media

Primovist / Eovist in Renally Impaired patients (PERI)

Bayer Identifier:

13701

ClinicalTrials.gov Identifier:

NCT00908596

EudraCT Number:

2008-005867-33

Study Completed

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- 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
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

St.-Johannes-Hospital Dortmund

Dortmund, Germany, 44137

Status
Completed
 
Locations

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Status
Completed
 
Locations

University of Michigan

Ann Arbor, United States, 48109

Status
Completed
 
Locations

Johns Hopkins University

Baltimore, United States, 21287

Status
Completed
 
Locations

Methodist Le Bonheur Healthcare

Memphis, United States, 38104

Status
Completed
 
Locations

Weill Cornell Medical College

New York, United States, 10021

Status
Completed
 
Locations

A.O. Spedali Civili di Brescia

Brescia, Italy, 25123

Status
Completed
 
Locations

IRCCS INT Fondazione Pascale

Napoli, Italy, 80131

Status
Completed
 
Locations

IRCCS Fondazione del Piemonte per l'Oncologia

Candiolo, Italy, 10060

Status
Terminated
 
Locations

ISMETT Ist Mediterraneo Trapianti e Terapie ad alta special

Palermo, Italy, 90127

Status
Completed
 
Locations

IRCCS Istituto Europeo Oncologia - IEO

Milano, Italy, 20141

Status
Completed
 
Locations

Westmead Hospital

Westmead NSW, Australia, 2145

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Pusan National University

Busan, South Korea, 602-739

Status
Completed
 
Locations

Kangnam St.Marry’s Hospital

Seoul, South Korea

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

SRH Wald-Klinikum Gera gGmbH

Gera, Germany, 07548

Status
Completed
 
Locations

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany, 39120

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Terminated
 
Locations

Universitätsklinikum Erlangen

Erlangen, Germany, 91054

Status
Terminated
 
Locations

Robert-Bosch-Krankenhaus

Stuttgart, Germany, 70376

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Terminated
 
Locations

Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35033

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Precise Clinical Research Solutions/ Midwest Radiology

Topeka, United States, 66604

Status
Terminated
 
Locations

University of Florida College of Medicine

Jacksonville, United States, 32209

Status
Completed
 
Locations

Maimonides Medical Center

Brooklyn, United States, 11219

Status
Terminated
 
Locations

University of Southern California-University Hospital

Los Angeles, United States, 90033

Status
Terminated
 
Locations

University of Texas MD Anderson Cancer Center

Houston, United States, 77030

Status
Terminated
 
Locations

University of Texas Health Science Center

San Antonio, United States, 78229

Status
Completed
 
Locations

Duke University Medical Center

Durham, United States, 27710

Status
Completed
 
Locations

Straub Clinic & Hospital

Honolulu, United States, 96813

Status
Terminated
 
Locations

A.O.U. Pisana

Pisa, Italy, 56124

Status
Completed
 
Locations

ASL NA/2 Pozzuoli - Campania

Pozzuoli, Italy, 80078

Status
Terminated
 
Locations

IRCCS Istituto Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 
Locations

Hospital Clínico Universitario San Cecilio

Granada, Spain, 18012

Status
Completed
 
Locations

Geelong Hospital

Geelong, Australia, 3220

Status
Terminated
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Completed
 
Locations

Royal Brisbane & Women's Hospital

Herston, Australia, 4029

Status
Completed
 
Locations

Princess Alexandra Hospital

Woollongabba, Australia, 4102

Status
Terminated
 
Locations

Seoul Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Prince of Songkla University

Songkhla , Thailand, 90110

Status
Completed
 
Locations

Ramathibodhi Hospital

Bangkok, Thailand

Status
Completed
 

Trial Design