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

September 6, 2018 updated by: Guerbet
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®

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Investigators

  • Study Director: Pierre DESCHE, MD, Guerbet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 4, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGD-55-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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