Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01467271
• Date of registration: 04/11/2011
• Prospective Registration: No
• Primary sponsor: Guerbet
• Public title: Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration NSsaFe
• Scientific title: Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
• Date of first enrolment: May 2011
• Target sample size: 540
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01467271
• Study type: Observational

Countries of recruitment

Argentina, Belgium, Colombia, France, Germany, Italy, Korea, Republic of, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Pierre Desché, MD
• Affiliation: Guerbet

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with moderate to severe and end stage renal impairment or dialysis, scheduled
for a contrast-enhanced Magnetic Resonance Imaging (MRI) with Dotarem

Exclusion Criteria:

- Patient who has received a Gadolinium Based Contrast Agent (GBCA) within the past 12
months prior to inclusion in this study except if the GBCA received is Dotarem



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Insufficiency

Primary Outcome(s)

Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem [Time Frame: All patients were followed up during 2 years after Dotarem administration.]

Secondary ID(s)

DGD-55-003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01467271