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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004496-22 | EudraCT Number |
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Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol (Gadovist, BAY86-4875) | Drug | Gadovist in approved indications at approved dosages |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information | From the time of MRI until the end of follow-up period (24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy was Obtained who Develop Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical Information | From the time of MRI until the end of follow-up period (24 months) | |
| Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | South Australia | 5000 | Australia | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| Immediately after Gadovist-enhanced MRI |
| Number of Participants With Image Quality Sufficient for Diagnosis | Immediately after Gadovist-enhanced MRI |
| Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment | Within 48 hours prior to the Gadovist administration |
| Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment | Within 48 hours prior to the Gadovist administration |
| Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairment | Within 48 hours prior to the Gadovist administration |
| Number of Participants With Treatmentemergent Adverse Events (TEAEs), Treatmentemergent Serious Adverse Event (TESAE), Drugrelated Treatmentemergent Adverse Events (TEAEs) and Drugrelated Treatmentemergent Serious Adverse Events (TESAEs) | From the time of MRI until the end of follow-up period (24 months) |
| Clayton |
| Victoria |
| 3168 |
| Australia |
| Geelong | Victoria | 3220 | Australia |
| Westmead NSW | 2145 | Australia |
| Innsbruck | Tyrol | 6020 | Austria |
| Ehenbichl | 6600 | Austria |
| Graz | 8036 | Austria |
| Leoben | 8700 | Austria |
| Vienna | 1030 | Austria |
| Vienna | 1090 | Austria |
| Calgary | Alberta | T2N 2T9 | Canada |
| Hamilton | Ontario | L8N 4A6 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5G 2N2 | Canada |
| Fleurimont | Quebec | J1H 5N4 | Canada |
| Le Kremlin-Bicêtre | 94275 | France |
| Lille | 59037 | France |
| Marseille | 13385 | France |
| Paris | 75908 | France |
| Reims | 51092 | France |
| Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Coburg | Bavaria | 96450 | Germany |
| Erlangen | Bavaria | 91054 | Germany |
| München | Bavaria | 81377 | Germany |
| Regensburg | Bavaria | 93053 | Germany |
| Neuruppin | Brandenburg | 16816 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 21031 | Germany |
| Frankfurt am Main | Hesse | 60596 | Germany |
| Hannoversch Münden | Lower Saxony | 34346 | Germany |
| Osnabrück | Lower Saxony | 49076 | Germany |
| Dortmund | North Rhine-Westphalia | 44263 | Germany |
| Essen | North Rhine-Westphalia | 45122 | Germany |
| Lüdenscheid | North Rhine-Westphalia | 58515 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04289 | Germany |
| Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Berlin | State of Berlin | 12200 | Germany |
| Berlin | State of Berlin | 12351 | Germany |
| Gera | Thuringia | 07548 | Germany |
| Rozzano | Milano | 20089 | Italy |
| Ancona | 60126 | Italy |
| Brescia | 25123 | Italy |
| Florence | 50139 | Italy |
| Genova | 16132 | Italy |
| Milan | 20132 | Italy |
| Milan | 20141 | Italy |
| Naples | 80131 | Italy |
| Pisa | 56124 | Italy |
| Roma | 00161 | Italy |
| Roma | 00168 | Italy |
| Torino | 10126 | Italy |
| Treviso | 31100 | Italy |
| Verona | 37134 | Italy |
| Seongnam-si | Gyeonggido | 463-707 | South Korea |
| Seoul | Seoul Teugbyeolsi | 110-744 | South Korea |
| Busan | 602-739 | South Korea |
| Jeonju-Si, Jeonrabuk-Do | 561-712 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 135-710 | South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 138-736 | South Korea |
| Barcelona | Barcelona | 08036 | Spain |
| Sabadell | Barcelona | 08208 | Spain |
| Granada | Granada | 18012 | Spain |
| Basel | Canton of Basel-City | 4031 | Switzerland |
| Lugano | Canton Ticino | 6900 | Switzerland |
| Bangkok | 10700 | Thailand |
| Bangkok | Thailand |
| Songkhla | 90110 | Thailand |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C090600 | gadobutrol |
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