Status:
COMPLETED
Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Nephrogenic Systemic Fibrosis
Eligibility:
All Genders
18+ years
Brief Summary
Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up...
Detailed Description
Phase 4, open-label, two-year, prospective, multi-center, follow-up study will be conducted in up to 15 active sites in the United States. All patients will receive 1 dose of Ablavar as part of an MRI...
Eligibility Criteria
Inclusion
- Kidney Disease with GFR \< 60 mL/min./1.73 m\^2. Clinical Need to Receive an MRI with Contrast. Understand \& Sign Informed Consent.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01135316
Start Date
October 1 2009
End Date
September 1 2013
Last Update
May 7 2014
Active Locations (2)
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1
Weill Cornell Medical College
New York, New York, United States, 10022
2
Duke University Medical Center
Durham, North Carolina, United States, 27710