Primovist / Eovist in Renally Impaired Patients
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2009 |
| End Date: | July 2013 |
Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Primovist/Eovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information.
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging
(MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to
participate.
The administration of contrast agents that contain gadolinium such as Primovist/Eovist might
increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis
(NSF) in patients with renal impairment. This study is to assess the potential risk to
develop NSF in patients with renal impairment after the administration of Primovist/Eovist.
Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan
which was prescribed by the referring doctor. After the MRI scan the patient will be
included in a two year follow-up period to assess if signs or symptoms suggestive of NSF
have appeared.
(MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to
participate.
The administration of contrast agents that contain gadolinium such as Primovist/Eovist might
increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis
(NSF) in patients with renal impairment. This study is to assess the potential risk to
develop NSF in patients with renal impairment after the administration of Primovist/Eovist.
Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan
which was prescribed by the referring doctor. After the MRI scan the patient will be
included in a two year follow-up period to assess if signs or symptoms suggestive of NSF
have appeared.
Adverse events data will be reported in Adverse Events section.
Inclusion Criteria:
- Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI)
of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the
recommended dose in one of the approved indications
- Patient must fulfill criteria for moderate (Estimated glomerular filtration rate
[eGFR] 30 - 59 mL/min/1.73 m^2) to severe (eGFR < 30 mL/min/1.73 m^2) renal
impairment.
Exclusion Criteria:
- Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for
any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to
administration of Primovist/Eovist
- History of existing NSF
We found this trial at
13
sites
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