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.