Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging.|
- To capture post-marketing safety information in patients with moderate renal insufficiency undergoing routine contrast-enhanced MRI with administration of OMNISCAN in order to assess the risk for developing nephrogenic systemic fibrosis. [ Time Frame: Time zero equals the date of Omniscan injection. All subjects will be followed for approximately 2 years after the administration of Omniscan ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||September 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908310
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Rubin Sheng, MD||GE Healthcare|