Clinical Trial: Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection

Study Status: Suspended
Recruit Status: Suspended
Study Type: Observational

Official Title: A Prospective Study for the Detection of Nephrogenic Systemic Fibrosis in Patients With Renal Impairment Undergoing Gadoversetamide-enhanced Magnetic Resonance Imaging

Brief Summary: The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (eGFR <30).

Detailed Summary:
Sponsor: Mallinckrodt

Current Primary Outcome: The primary outcome measure will be the diagnosis of NSF based on clinical assessments and patient telephone calls through 24 months of follow-up. [ Time Frame: 1, 3, 6, 12, 18 and 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mallinckrodt

Dates:
Date Received: December 18, 2008
Date Started: February 2009
Date Completion: February 2013
Last Updated: March 15, 2010
Last Verified: March 2010