Status:
COMPLETED
Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist
Lead Sponsor:
Bayer
Conditions:
Fibrosis
Kidney Failure
Eligibility:
All Genders
2+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- Patients must have moderate (eGFR 30-59 ml/min/1.73 m\^2) renal impairment and be scheduled for a contrast enhanced MRI with Magnevist Injection at the recommended dose of 0.1 mmol/kg.
Exclusion
- Gadolinium Based Contrast Agent (other then Magnevist) enhanced MRI within 12 months prior to administration of Magnevist
- History of NSF
- Clinically unstable or age \<2 yrs
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00744939
Start Date
November 1 2008
End Date
November 1 2013
Last Update
September 22 2014
Active Locations (26)
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1
Phoenix, Arizona, United States, 85008
2
Chula Vista, California, United States, 91910
3
Los Angeles, California, United States, 90033
4
Santa Rosa, California, United States, 95405