Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration (NSsaFe)

Guerbet

Status: Completed

Conditions: Renal Insufficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT01467271

DGD-55-003

Details and patient eligibility

About

The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®

Full description

All patients will be followed up during 2 years after Dotarem® administration to collect data on any suspected NSF or NSF-related symptoms

Enrollment: 540 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem

Exclusion criteria

• Patient who has received a Gadolinium Based Contrast Agent (GBCA) within the past 12 months prior to inclusion in this study except if the GBCA received is Dotarem

Trial design