Clinical trial NCT01467271: Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
Official title: Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2011-11-08
Enrollment: 540
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients with moderate to severe and end stage renal impairment or dialysis
* Patients scheduled for a contrast-enhanced MRI with Dotarem

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 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

Primary outcomes:
measure: Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem
timeFrame: All patients were followed up during 2 years after Dotarem administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Saginaw
country: United States
facility: Covenant Health Care
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: Philadelphia
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Brussel
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: AZ St Lucas
city: Roeselare
country: Belgium
facility: H. Hartziekenhuis
city: Bogota
country: Colombia
facility: Hospital Universitario de San Ignacio
city: Medellin
country: Colombia
facility: IATM (Instituto de alta tecnologia Medica de Antoquia)
city: Paris
country: France
facility: Hôpital Necker - Enfants malades
city: Rouen
country: France
facility: Hôpital Bois-Guillaume - CHU de Rouen
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Frankfurt
country: Germany
facility: Institute of Radiology and Neuroradiology
city: Napoli
country: Italy
facility: Instituto Tumori Pascale
city: Pozzuoli
country: Italy
facility: Ospedale Santa Maria
city: Roma
country: Italy
facility: Universita campus Biomedico
city: Gyeonggi-do
country: Korea, Republic of
facility: Soonchunhyang Univ. Bucheon Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univ. Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos de Madrid
city: Reus
country: Spain
facility: CRC Hospital Universitari Sant Joan de Reus
city: Ankara
country: Turkey
facility: Dişkapi Etlik Polikliniği
city: Istanbul
country: Turkey
facility: Medeniyet University Goztepe Research and Training Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Staffodshire
Study officials:
affiliation: Guerbet
name: Pierre Desché, MD
role: STUDY_DIRECTOR
References: