Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/6/2019 |
| Start Date: | May 2011 |
| End Date: | June 2017 |
The main purpose of this study is to prospectively estimate the incidence of Nephrogenic
Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after
administration of Dotarem®
Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after
administration of Dotarem®
All patients will be followed up during 2 years after Dotarem® administration to collect data
on any suspected NSF or NSF-related symptoms
on any suspected NSF or NSF-related symptoms
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
We found this trial at
5
sites
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