Conditions: Contrast Media
Keywords: Nephrogenic Systemic Fibrosis (NSF) Primovist / Eovist
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 357
Healthy volunteers: no

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 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.

Detailed description:
Adverse events data will be reported in Adverse Events section.

Arms:
arm 1: Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.

Interventions: intervention 1: Gadoxetic acid disodium (Primovist, BAY86-4873)
Intervention descriptions: intervention 1: Primovist/Eovist in approved indications at approved dosages

Protocol document: