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

NCT ID: NCT00908310

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-09-30

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 administered intravenously at the medical discretion of the prescribing physician.

Conditions

Chronic Kidney Disease; Renal Insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Omniscan

Group Type: OTHER

Omniscan

Intervention Type: DRUG

OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.

Interventions

Omniscan

OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.

Intervention Type: DRUG

Other Intervention Names

Gadodiamide

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

i3 Statprobe

INDUSTRY

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubin Sheng, MD

Role: STUDY_DIRECTOR

GE Healthcare

Locations

GE Healthcare

Princeton, New Jersey, United States

Countries

United States

Other Identifiers

GE-041-075

Identifier Type: -

Identifier Source: org_study_id