Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection

A Prospective Study for the Detection of Nephrogenic Systemic Fibrosis in Patients With Renal Impairment Undergoing Gadoversetamide-enhanced Magnetic Resonance Imaging

The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (eGFR <30).

Inclusion Criteria:

• Referred for contrast-enhanced MRI using gadoversetamide;
• Have a documented estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 within the past 6 months or ESRD requiring dialysis; and
• Willing and able to provide written consent (themselves or by a legally authorized representative) and agree to abide by study requirements, including being seen by a dermatologist and undergoing a skin biopsy if NSF is suspected.

Exclusion Criteria:

• Have experienced a previous hypersensitivity reaction to a GBCA;
• Have pre-existing NSF or NSF-like symptoms; or
• Have been exposed to a GBCA within 12 months prior to the index procedure; or
• Has a medical condition or other personal situation that would prevent providing follow-up information, completing clinic visits or otherwise supplying meaningful data to meet study objectives.