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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00908310 |
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Date of registration:
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13/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
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Scientific title:
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A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging. |
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Date of first enrolment:
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May 2009 |
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Target sample size:
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213 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00908310 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Rubin Sheng, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GE Healthcare |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Renal Insufficiency
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Chronic Kidney Disease
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Intervention(s)
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Drug: Omniscan
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Primary Outcome(s)
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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.]
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Secondary ID(s)
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GE-041-075
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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