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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01467271
First Posted: November 8, 2011
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Guerbet
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 4, 2011
First Posted: November 8, 2011
Last Update Posted: February 2, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases