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

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ClinicalTrials.gov Identifier: NCT01467271
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Guerbet

Brief Summary:
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 or disease
Renal Insufficiency

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
Actual Enrollment : 540 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on the Incidence of NSF in Renal Impaired Patients Following DOTAREM Administration
Study Start Date : April 2011
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01467271     History of Changes
Other Study ID Numbers: DGD-55-003
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases