Status:
COMPLETED
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
i3 Statprobe
Conditions:
Chronic Kidney Disease
Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be ...
Eligibility Criteria
Inclusion
- The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
- The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and \<60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration.
- The subject agrees to be contacted for follow-up for 24 months.
Exclusion
- Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:
- skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
- eyes - yellow raised spots on whites of eyes; or
- bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness.
- Patients allergic to any GBCA.
- Patients with chronic renal disease with a GFR \<30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
- Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri operative liver transplantation period.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00908310
Start Date
May 1 2009
End Date
September 1 2013
Last Update
July 17 2014
Active Locations (1)
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1
GE Healthcare
Princeton, New Jersey, United States, 08540