Expired Study
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Youngstown, Ohio 44512


Purpose:

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).


Criteria:

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.


NCT ID:

NCT00811863


Primary Contact:

Study Director
Herbert R. Neuman, MD
Mallinckrodt


Backup Contact:

N/A


Location Contact:

Youngstown, Ohio 44512
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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