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

General Electric (GE)

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Renal Insufficiency

Treatments: Drug: Omniscan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00908310

GE-041-075

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

213 participants in 1 patient group

Omniscan

Other group

Treatment:

Drug: Omniscan