Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
357 participants
INTERVENTIONAL
2009-05-31
2013-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Gadoxetic acid disodium (Primovist/Eovist, BAY86-4873)
Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.
Gadoxetic acid disodium (Primovist, BAY86-4873)
Primovist/Eovist in approved indications at approved dosages
Interventions
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Gadoxetic acid disodium (Primovist, BAY86-4873)
Primovist/Eovist in approved indications at approved dosages
Eligibility Criteria
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Inclusion Criteria
* 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
* History of existing NSF
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Los Angeles, California, United States
Jacksonville, Florida, United States
Honolulu, Hawaii, United States
Topeka, Kansas, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Brooklyn, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Memphis, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Herston, Queensland, Australia
Woollongabba, Queensland, Australia
Adelaide, South Australia, Australia
Geelong, Victoria, Australia
Westmead NSW, , Australia
Graz, , Austria
Vienna, , Austria
Heidelberg, Baden-Wurttemberg, Germany
Stuttgart, Baden-Wurttemberg, Germany
Erlangen, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Marburg, Hesse, Germany
Hanover, Lower Saxony, Germany
Dortmund, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Gera, Thuringia, Germany
Rozzano, Milano, Italy
Pozzuoli, Napoli, Italy
Candiolo, Torino, Italy
Brescia, , Italy
Milan, , Italy
Napoli, , Italy
Palermo, , Italy
Pisa, , Italy
Busan, South Korea, South Korea
Seoul, South Korea, South Korea
Seoul, , South Korea
Granada, Granada, Spain
Bangkok, , Thailand
Bangkok, , Thailand
Songkhla, , Thailand
Bristol, , United Kingdom
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2008-005867-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13701
Identifier Type: -
Identifier Source: org_study_id
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