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

Phase 4

Completed

• Conditions: Renal Insufficiency; Chronic Kidney Disease
• Interventions: Drug: Omniscan

• Registration Number: NCT00908310
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Results First Submitted: 2014-06-17
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-16
• Last Update Submitted: 2014-07-16
• Results First Posted: 2014-07-17
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omniscan	Omniscan	-

Primary Outcome Measures

Name	Time	Method
Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).	Greater than or equal to 7 days post contrast administration.	Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States