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

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ClinicalTrials.gov Identifier: NCT00908310

Recruitment Status : Completed

First Posted : May 25, 2009

Results First Posted : July 17, 2014

Last Update Posted : July 17, 2014

Sponsor:

Collaborator:

i3 Statprobe

Information provided by (Responsible Party):

GE Healthcare

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Kidney Disease Renal Insufficiency	Drug: Omniscan	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	213 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging.
Study Start Date :	May 2009
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans Safety

Drug Information available for: Gadodiamide

Genetic and Rare Diseases Information Center resources: Nephrogenic Systemic Fibrosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Omniscan	Drug: Omniscan OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician. Other Name: Gadodiamide

Outcome Measures

Primary Outcome Measures :

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). [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908310

Locations

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United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

GE Healthcare

i3 Statprobe

Investigators

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Study Director:	Rubin Sheng, MD	GE Healthcare

More Information

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Responsible Party:	GE Healthcare
ClinicalTrials.gov Identifier:	NCT00908310
Other Study ID Numbers:	GE-041-075
First Posted:	May 25, 2009 Key Record Dates
Results First Posted:	July 17, 2014
Last Update Posted:	July 17, 2014
Last Verified:	July 2014

Keywords provided by GE Healthcare:


CKD - Chronic Kidney Disease GBCA - Gadolinium-based contrast agent GFR - Glomerular Filtration Rate	MRI - Magnetic Resonance Imaging NSF - Nephrogenic Systemic Fibrosis Known or suspected CKD with an eGFR greater than or equal to 30mL & less than 60 mL/min/1.73m2 as measured within 30 days prior to the OMNISCAN.

Additional relevant MeSH terms:

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Kidney Diseases Renal Insufficiency, Chronic Renal Insufficiency Urologic Diseases

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