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

Completed

Conditions studied: Renal Insufficiency

In brief

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®

Key facts

Study ID

NCT01467271

Run by

Guerbet

People needed

540

Starts

2011-05-01

Expected to finish

2017-06-01

Last updated by the study team

2019-02-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem

You may not qualify if…

• 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

Where it is running

• Covenant Health Care — Saginaw, Michigan, United States
• St. Louis University Medical Center — St 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 — Brussels, Belgium
• AZ St Lucas — Ghent, Belgium
• H. Hartziekenhuis — Roeselare, Belgium
• Hospital Universitario de San Ignacio — Bogotá, Colombia
• IATM (Instituto de alta tecnologia Medica de Antoquia) — Medellín, Colombia
• Hôpital Necker - Enfants malades — Paris, France
• Hôpital Bois-Guillaume - CHU de Rouen — Rouen, France
• Cardioangiologisches Centrum Bethanien — Frankfurt, Germany
• Institute of Radiology and Neuroradiology — Frankfurt, Germany
• Instituto Tumori Pascale — Naples, Italy
• Ospedale Santa Maria — Pozzuoli, Italy
• Universita campus Biomedico — Roma, Italy
• Soonchunhyang Univ. Bucheon Hospital — Gyeonggi-do, South Korea
• Uijeongbu St. Mary's Hospital — Gyeonggi-do, South Korea
• Chung-Ang Univ. Medical Center — Seoul, South Korea
• Ewha Womans University Mokdong Hospital — Seoul, South Korea
• Hospital Clínico San Carlos de Madrid — Madrid, Spain
• CRC Hospital Universitari Sant Joan de Reus — Reus, Spain
• Dişkapi Etlik Polikliniği — Ankara, Turkey (Türkiye)
• Medeniyet University Goztepe Research and Training Hospital — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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