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 studied: Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT00773409

Run by

Bracco Diagnostics, Inc

People needed

405

Starts

2008-10-01

Expected to finish

2012-07-01

Last updated by the study team

2012-09-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Bracco Diagnostics Inc. — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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