NCT00773409

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 405 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Insufficiency

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2008-10-16
• Last updated: 2012-09-18

Locations

1 site across 1 country: United States