Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
- Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
H. Hartziekenhuis
🇧🇪Roeselare, Belgium
Chung-Ang Univ. Medical Center
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Clínico San Carlos de Madrid
🇪🇸Madrid, Spain
Hospital Universitario de San Ignacio
🇨🇴Bogota, Colombia
CRC Hospital Universitari Sant Joan de Reus
🇪🇸Reus, Spain
Hôpital Bois-Guillaume - CHU de Rouen
🇫🇷Rouen, France
Dişkapi Etlik Polikliniği
🇹🇷Ankara, Turkey
Cardioangiologisches Centrum Bethanien
🇩🇪Frankfurt, Germany
Uijeongbu St. Mary's Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
AZ St Lucas
🇧🇪Gent, Belgium
Medeniyet University Goztepe Research and Training Hospital
🇹🇷Istanbul, Turkey
University Hospital of North Staffodshire
🇬🇧Stoke-on-Trent, United Kingdom
Covenant Health Care
🇺🇸Saginaw, Michigan, United States
Hôpital Necker - Enfants malades
🇫🇷Paris, France
Soonchunhyang Univ. Bucheon Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
UZ Brussel
🇧🇪Brussel, Belgium
Universita campus Biomedico
🇮🇹Roma, Italy
St. Louis University Medical Center
🇺🇸Saint Louis, Missouri, United States
IATM (Instituto de alta tecnologia Medica de Antoquia)
🇨🇴Medellin, Colombia
Instituto Tumori Pascale
🇮🇹Napoli, Italy
Institute of Radiology and Neuroradiology
🇩🇪Frankfurt, Germany
Ospedale Santa Maria
🇮🇹Pozzuoli, Italy
Abington Memorial Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom