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

Chronic Kidney Disease Clinical Trial

Official title:

A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908310
• Other study ID #: GE-041-075
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2009
• Last updated: July 16, 2014
• Start date: May 2009
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Drugs Controller General of IndiaCanada: Health CanadaChina: Food and Drug AdministrationTaiwan: Department of HealthSpain: Spanish Agency of MedicinesBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Omniscan
OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	i3 Statprobe

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.	Greater than or equal to 7 days post contrast administration.	Yes