Status:
COMPLETED
Primovist / Eovist in Renally Impaired Patients
Lead Sponsor:
Bayer
Conditions:
Contrast Media
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 admini...
Detailed Description
Adverse events data will be reported in Adverse Events section.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT00908596
Start Date
May 1 2009
End Date
July 1 2013
Last Update
July 23 2015
Active Locations (47)
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1
Los Angeles, California, United States, 90033
2
Jacksonville, Florida, United States, 32209
3
Honolulu, Hawaii, United States, 96813
4
Topeka, Kansas, United States, 66604