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

Completed

• Conditions: Renal Insufficiency

• Registration Number: NCT00773409
• Lead Sponsor: Bracco Diagnostics, Inc

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 Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

• Has CKD with an eGFR below 30 mL/min/1.73m2 and/or undergoing dialysis as calculated from a serum creatinine (SCr) value obtained from the local laboratory within 24 hours prior to signing the informed consent;
• Provides written informed consent and is willing to comply with protocol requirements

Exclusion Criteria

• Has received a GBCA within the past 10 years prior to inclusion in this study including the administration of a GBCA for something other than an MRI (e.g., CT or DSA);
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
• Has ever been suspected of, or diagnosed with, NSF;
• Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of NSF be suspected.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1,3,6,12,18,24 months

Trial Locations

Locations (1)

Bracco Diagnostics Inc.; 🇺🇸 Princeton, New Jersey, United States