Status:
COMPLETED
Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
Lead Sponsor:
Guerbet
Conditions:
Renal Insufficiency
Eligibility:
All Genders
Brief 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
Eligibility Criteria
Inclusion
- Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT01467271
Start Date
May 1 2011
End Date
June 1 2017
Last Update
February 4 2019
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Covenant Health Care
Saginaw, Michigan, United States
2
St. Louis University Medical Center
St Louis, Missouri, United States
3
Abington Memorial Hospital
Philadelphia, Pennsylvania, United States
4
University of Texas Health Science Center
San Antonio, Texas, United States