Status:
COMPLETED
Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Renal Insufficiency
Eligibility:
All Genders
Brief Summary
The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with ...
Eligibility Criteria
Inclusion
- Has CKD with an eGFR below 30 mL/min/1.73m2 and/or undergoing dialysis as calculated from a serum creatinine (SCr) value obtained from the local laboratory within 24 hours prior to signing the informed consent;
- Provides written informed consent and is willing to comply with protocol requirements
Exclusion
- Has received a GBCA within the past 10 years prior to inclusion in this study including the administration of a GBCA for something other than an MRI (e.g., CT or DSA);
- Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
- Has ever been suspected of, or diagnosed with, NSF;
- Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of NSF be suspected.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00773409
Start Date
October 1 2008
End Date
July 1 2012
Last Update
September 18 2012
Active Locations (1)
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1
Bracco Diagnostics Inc.
Princeton, New Jersey, United States, 08540