Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Completed · Phase 4
Conditions studied: Chronic Kidney Disease, Renal Insufficiency
In brief
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 administered intravenously at the medical discretion of the prescribing physician.
Key facts
- Study ID
- NCT00908310
- Run by
- GE Healthcare
- People needed
- 213
- Starts
- 2009-05-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2014-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- GE Healthcare — Princeton, New Jersey, United States
Full record on ClinicalTrials.gov
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