Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
927 participants
INTERVENTIONAL
2008-12-31
2015-01-31
Brief Summary
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The administration of contrast agents that contain gadolinium such as Gadovist 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 Gadovist. Patients who are enrolled in this study will receive a Gadovist 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
TREATMENT
NONE
Study Groups
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Arm 1
Gadobutrol (Gadovist, BAY86-4875)
Gadovist in approved indications at approved dosages
Interventions
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Gadobutrol (Gadovist, BAY86-4875)
Gadovist in approved indications at approved dosages
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of NSF (Nephrogenic Fibrosing Dermopathy)
* Age outside the indicated age range mentioned in national labelling.
2 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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Adelaide, South Australia, Australia
Clayton, Victoria, Australia
Geelong, Victoria, Australia
Westmead NSW, , Australia
Innsbruck, Tyrol, Austria
Ehenbichl, , Austria
Graz, , Austria
Leoben, , Austria
Vienna, , Austria
Vienna, , Austria
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Fleurimont, Quebec, Canada
Le Kremlin-Bicêtre, , France
Lille, , France
Marseille, , France
Paris, , France
Reims, , France
Mannheim, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
Coburg, Bavaria, Germany
Erlangen, Bavaria, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Neuruppin, Brandenburg, Germany
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Hannoversch Münden, Lower Saxony, Germany
Osnabrück, Lower Saxony, Germany
Dortmund, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Lüdenscheid, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Magdeburg, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Gera, Thuringia, Germany
Rozzano, Milano, Italy
Ancona, , Italy
Brescia, , Italy
Florence, , Italy
Genova, , Italy
Milan, , Italy
Milan, , Italy
Napoli, , Italy
Pisa, , Italy
Roma, , Italy
Roma, , Italy
Torino, , Italy
Treviso, , Italy
Verona, , Italy
Seongnam-si, Gyeonggido, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Busan, , South Korea
Jeonju-Si, Jeonrabuk-Do, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Barcelona, Barcelona, Spain
Sabadell, Barcelona, Spain
Granada, Granada, Spain
Basel, Canton of Basel-City, Switzerland
Lugano, Canton Ticino, Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Songkhla, , Thailand
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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2008-004496-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
13273
Identifier Type: -
Identifier Source: org_study_id
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