NCT00828737

Safety of Gadovist in Renally Impaired Patients

Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Gadovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 927 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fibrosis
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadovist, BAY86-4875)	Gadovist in approved indications at approved dosages

Timeline

• Start date: 2008-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2009-01-26
• Last updated: 2016-02-18

Locations

70 sites across 10 countries: Australia, Austria, Canada, France, Germany, Italy, South Korea, Spain, Switzerland, Thailand