Overview

Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)

Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
0
Participant gender:
All
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 administered intravenously at the medical discretion of the prescribing physician.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GE Healthcare
Collaborator:
i3 Statprobe
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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:

1. skin - swelling, hardening and tightening; reddened or darkened patches; burning
or itching;

2. eyes - yellow raised spots on whites of eyes; or

3. 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.