- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135316
Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR
A Phase 4, Open-Label, Prospective Evaluation of the Incidence of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate to Severe Kidney Disease Undergoing Magnetic Resonance Imaging (MRI) With Ablavar (Gadofosveset Trisodium) in Routine Clinical Practice
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10022
- Weill Cornell Medical College
-
-
North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Kidney Disease with GFR < 60 mL/min./1.73 m^2. Clinical Need to Receive an MRI with Contrast. Understand & Sign Informed Consent.
Exclusion Criteria:
History of known or suspected NSF. Has received any gadolinium based contrast agent within 12 months prior to enrollment.
Has a clinically significant skin disorder which may interfere with detection of cutaneous NSF manifestations.
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives.
Is unable or unwilling to return for necessary office visits or follow up calls, and/or to be examined by a physician or undergo deep skin biopsy should the development of NSF be suspected.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Nephrogenic Systemic Fibrosis
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Simon P Robinson, PhD, Lantheus Medical Imaging
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMI-Ablavar-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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