Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist
| Status: | Archived |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2008 |
| End Date: | June 2013 |
Prospective Non-randomized Observational (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Magnevist® Injection in Patients With Moderate Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information.
Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist
injection. Subjects will be screened within 48 hours of previously scheduled MRI, those
meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post
MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls
conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.
We found this trial at
16
sites
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