Clinical Trial: Evaluation of the Risk of NSF Following MultiHance Injection in Patients With Chronic Kidney Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective Cohort Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 3 to 5 Chronic Kidney Disease Undergoing MRI With the Injectio
Brief Summary: The objective of this long-term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1 - patients with moderate chronic kidney disease eGFR 30 to 59 and Cohort 2 - patients with severe chronic kidney disease or kidney failure eGFR <30).
Detailed Summary:
Sponsor: Bracco Diagnostics, Inc
Current Primary Outcome: To estimate and compare the incidence of NSF in the two cohorts defined for each cohort as the number of cases of NSF observed during the follow-up time period over the total number of eligible patients. [ Time Frame: 1, 3, 6, 12, 18 and 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Bracco Diagnostics, Inc
Dates:
Date Received: January 14, 2008
Date Started: January 2008
Date Completion:
Last Updated: October 31, 2014
Last Verified: October 2014