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

Lead Sponsor

Bracco Diagnostics, Inc

Age

All ages

Sex

ALL

Healthy Volunteers

No

•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

•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.