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

This study is currently recruiting participants.
Verified November 2011 by Guerbet
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01467271
First received: November 4, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
  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 ]

Estimated Enrollment: 1000
Study Start Date: April 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

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

Contacts
Contact: Emilie HUCHET +33.1.45.91.50.00 ext 7688 emilie.huchet@guerbet-group.com
Contact: Corinne DUBOURDIEU, PharmD +33.1.45.91.50.00 ext 5184 corinne.dubourdieu@guerbet-group.com

Locations
France
GUERBET Recruiting
Roissy, France, 95943
Contact: Emilie HUCHET    +33.1.45.91.50.00 ext 7688    emilie.huchet@guerbet-group.com   
Contact: Corinne DUBOURDIEU, PharmD    +33.1.45.91.50.00 ext 5184    corinne.dubourdieu@guerbet-group.fr   
Sponsors and Collaborators
Guerbet
  More Information

No publications provided

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: November 4, 2011
Health Authority: Belgium: Ethics Committee
Brazil: Ethics Committee
Brazil: National Health Surveillance Agency
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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014