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

Completed

• Conditions: Renal Insufficiency

• Registration Number: NCT01467271
• Lead Sponsor: Guerbet

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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-08
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-09
• Results First Submitted: 2018-09-06
• Results First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Results First Posted: 2019-02-04
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem	All patients were followed up during 2 years after Dotarem administration.

Trial Locations

Locations (27)

Covenant Health Care; 🇺🇸 Saginaw, Michigan, United States

St. Louis University Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Abington Memorial Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Health Science Center; 🇺🇸 San Antonio, Texas, United States

Hospital Italiano de Buenos Aires; 🇦🇷 Buenos Aires, Argentina

UZ Brussel; 🇧🇪 Brussel, Belgium

AZ St Lucas; 🇧🇪 Gent, Belgium

H. Hartziekenhuis; 🇧🇪 Roeselare, Belgium

Hospital Universitario de San Ignacio; 🇨🇴 Bogota, Colombia

IATM (Instituto de alta tecnologia Medica de Antoquia); 🇨🇴 Medellin, Colombia

Scroll for more (17 remaining)