Clinical Trial: Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Co

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 an eGFR below 30)who have not had exposure to a GBCA within 10 years prior to enrollment.

Detailed Summary:
Sponsor: Bracco Diagnostics, Inc

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bracco Diagnostics, Inc

Dates:
Date Received: October 15, 2008
Date Started: October 2008
Date Completion:
Last Updated: September 14, 2012
Last Verified: September 2012