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

This study has been completed.
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00908310
First received: May 13, 2009
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Renal Insufficiency
Drug: Omniscan
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • To capture 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. [ Time Frame: Time zero equals the date of Omniscan injection. All subjects will be followed for approximately 2 years after the administration of Omniscan ] [ Designated as safety issue: Yes ]

Enrollment: 213
Study Start Date: May 2009
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Omniscan Drug: Omniscan
OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.
Other Names:
  • Omniscan
  • Gadodiamide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00908310

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Investigators
Study Director: Rubin Sheng, MD GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00908310     History of Changes
Other Study ID Numbers: GE-041-075
Study First Received: May 13, 2009
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Canada: Health Canada
China: Food and Drug Administration
Taiwan: Department of Health
Spain: Spanish Agency of Medicines
Brazil: Ministry of Health

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:
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on April 22, 2014