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NCT01467271 Clinical Trial

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

Renal Insufficiency Clinical Trial

— NSsaFe  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01467271
Other study ID # DGD-55-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2011
Est. completion date June 2017

Study information
Verified date September 2018
Source Guerbet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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®

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 540
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Hospital Italiano de Buenos Aires Buenos Aires
Belgium UZ Brussel Brussel
Belgium AZ St Lucas Gent
Belgium H. Hartziekenhuis Roeselare
Colombia Hospital Universitario de San Ignacio Bogota
Colombia IATM (Instituto de alta tecnologia Medica de Antoquia) Medellin
France Hôpital Necker - Enfants malades Paris
France Hôpital Bois-Guillaume - CHU de Rouen Rouen
Germany Cardioangiologisches Centrum Bethanien Frankfurt
Germany Institute of Radiology and Neuroradiology Frankfurt
Italy Instituto Tumori Pascale Napoli
Italy Ospedale Santa Maria Pozzuoli
Italy Universita campus Biomedico Roma
Korea, Republic of Soonchunhyang Univ. Bucheon Hospital Gyeonggi-do
Korea, Republic of Uijeongbu St. Mary's Hospital Gyeonggi-do
Korea, Republic of Chung-Ang Univ. Medical Center Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul
Spain Hospital Clínico San Carlos de Madrid Madrid
Spain CRC Hospital Universitari Sant Joan de Reus Reus
Turkey Diskapi Etlik Poliklinigi Ankara
Turkey Medeniyet University Goztepe Research and Training Hospital Istanbul
United Kingdom Royal Liverpool University Hospital Liverpool
United Kingdom University Hospital of North Staffodshire Stoke-on-Trent
United States Abington Memorial Hospital Philadelphia Pennsylvania
United States Covenant Health Care Saginaw Michigan
United States St. Louis University Medical Center Saint Louis Missouri
United States University of Texas Health Science Center San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Guerbet

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Colombia,  France,  Germany,  Italy,  Korea, Republic of,  Spain,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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