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: July 16, 2014
Last verified: July 2014
  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:
  • 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. ] [ Designated as safety issue: Yes ]
    Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: June 17, 2014
Last Updated: July 16, 2014
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, Chronic
Renal Insufficiency
Urologic Diseases
Gadodiamide
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014