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

Guerbet540 enrolled

Overview

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®

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

Study Type

OBSERVATIONAL

Enrollment

540

Conditions

Renal Insufficiency

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (27)

Covenant Health Care

Saginaw, Michigan, United States

Outcomes

Primary Outcomes

Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem

Time frame: All patients were followed up during 2 years after Dotarem administration.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.