Clinical Trial: Evaluation of the Risk of NSF Following ProHance 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 30-59 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. The incidence is 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 15, 2008
Date Started: February 2008
Date Completion:
Last Updated: October 31, 2014
Last Verified: October 2014