Status:
COMPLETED
Safety of Gadovist in Renally Impaired Patients
Lead Sponsor:
Bayer
Conditions:
Fibrosis
Renal Impairment
Eligibility:
All Genders
2+ years
Phase:
PHASE4
Brief Summary
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate. The administration...
Eligibility Criteria
Inclusion
- Patients with moderate (eGFR 30 - 59 ml/min/173m2) or severe (eGFR \< 30 ml/min/1.73m2) renal impairment, scheduled to undergo Gadovist-enhanced MRI
Exclusion
- GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Gadovist within 12 months prior to administration of Gadovist
- History of NSF (Nephrogenic Fibrosing Dermopathy)
- Age outside the indicated age range mentioned in national labelling.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
927 Patients enrolled
Trial Details
Trial ID
NCT00828737
Start Date
December 1 2008
End Date
January 1 2015
Last Update
February 18 2016
Active Locations (70)
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1
Adelaide, South Australia, Australia, 5000
2
Clayton, Victoria, Australia, 3168
3
Geelong, Victoria, Australia, 3220
4
Westmead NSW, Australia, 2145