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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01467271
First received: November 4, 2011
Last updated: September 23, 2015
Last verified: September 2015
  Purpose
The main purpose of this study is to prospectively estimate the incidence of NSF in patients with moderate to severe renal impairment after administration of DOTAREM®

Condition
Renal Insufficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on the Incidence of NSF in Renal Impaired Patients Following DOTAREM Administration

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Number of patients with moderate to severe renal impairment who develop Nephrogenic Systemic Fibrosis after administration of DOTAREM [ Time Frame: Within 2 years after Dotarem administration ] [ Designated as safety issue: Yes ]

Enrollment: 540
Study Start Date: April 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast enhanced MRI with DOTAREM

Exclusion Criteria:

  • Patient who has received a Gadolinium Based Contrast Agent within the past 12 months prior to inclusion in this study except if the GBCA received is Dotarem
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467271

  Show 28 Study Locations
Sponsors and Collaborators
Guerbet
  More Information

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01467271     History of Changes
Other Study ID Numbers: DGD-55-003 
Study First Received: November 4, 2011
Last Updated: September 23, 2015
Health Authority: Belgium: Ethics Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Commission nationale de l'informatique et des libertés
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Korea: Institutional Review Board
Spain: Ethics Committee
Turkey: Ministry of Health
United States: Institutional Review Board
Turkey: Ethics Committee
Colombia: Ethics Committee
Argentina: Ministry of Health

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2016