Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)
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 an eGFR below 30)who have not had exposure to a GBCA within 10 years prior to enrollment.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||A Prospective Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 4 to 5 Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents Within the Past 10 Years|
- To estimate the incidence of NSF in patients that have not been exposed to GBCA within the last 10 years with severe CKD including those undergoing dialysis observed during the follow-up time period over the total number of eligible patients. [ Time Frame: 1,3,6,12,18,24 months ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
fixed tissue samples and tissue sample for testing of GBCA.
|Study Start Date:||October 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773409
|United States, New Jersey|
|Bracco Diagnostics Inc.|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Gianpaolo Pirovano, MD||Bracco Diagnostics, Inc|