Primovist / Eovist in Renally Impaired Patients

Completed · Phase 4

Conditions studied: Contrast Media

In brief

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 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.

Key facts

Study ID

NCT00908596

Run by

Bayer

People needed

357

Starts

2009-05-01

Expected to finish

2013-07-01

Last updated by the study team

2015-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Topeka, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Brooklyn, New York, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Herston, Queensland, Australia
• Study site — Woollongabba, Queensland, Australia
• Study site — Adelaide, South Australia, Australia
• Study site — Geelong, Victoria, Australia
• Study site — Westmead NSW, Australia
• Study site — Graz, Austria
• Study site — Vienna, Austria
• Study site — Heidelberg, Baden-Wurttemberg, Germany
• Study site — Stuttgart, Baden-Wurttemberg, Germany
• Study site — Erlangen, Bavaria, Germany
• Study site — Frankfurt am Main, Hesse, Germany
• Study site — Marburg, Hesse, Germany
• Study site — Hanover, Lower Saxony, Germany

Full record on ClinicalTrials.gov

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