Clinical Trials Directory

Trials / Completed

CompletedNCT01467271

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

Status
Completed
Phase
Study type
Observational
Enrollment
540 (actual)
Sponsor
Guerbet · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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®

Detailed description

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

Conditions

Timeline

Start date
2011-05-01
Primary completion
2017-06-01
Completion
2017-06-01
First posted
2011-11-08
Last updated
2019-02-04
Results posted
2019-02-04

Locations

27 sites across 11 countries: United States, Argentina, Belgium, Colombia, France, Germany, Italy, South Korea, Spain, Turkey (Türkiye), United Kingdom

Source: ClinicalTrials.gov record NCT01467271. Inclusion in this directory is not an endorsement.