This trial is active, not recruiting.

Condition renal insufficiency
Sponsor Guerbet
Start date April 2011
End date June 2017
Trial size 540 participants
Trial identifier NCT01467271, DGD-55-003


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®

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Observational Study on the Incidence of NSF in Renal Impaired Patients Following DOTAREM Administration
Description All patients will be followed up during 2 years after DOTAREM® administration to collect data on any suspected NSF or NSF related symptoms
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Guerbet.