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



Status:Withdrawn
Conditions:Renal Impairment / Chronic Kidney Disease, Neurology
Therapuetic Areas:Nephrology / Urology, Neurology
Healthy:No
Age Range:Any
Updated:8/3/2017
Start Date:February 2009
End Date:May 17, 2012

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Trial Summary
Trial Overview
Inclusion Criteria

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.
We found this trial at
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Radiology Consultants, Inc.
Youngstown, Ohio
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Youngstown, OH
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