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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773409
• Other study ID #: NSF-101
• Status: Completed
• Phase: N/A
• First received: October 15, 2008
• Last updated: September 14, 2012
• Start date: October 2008
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Diseases
• Nephrogenic Fibrosing Dermopathy
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Bracco Diagnostics Inc.	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes