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

Withdrawn before enrolling

Conditions studied: Nephrogenic Systemic Fibrosis, Renal Insufficiency

In brief

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).

Key facts

Study ID

NCT00811863

Run by

Guerbet

People needed

0

Starts

2009-02-01

Expected to finish

2012-05-17

Last updated by the study team

2017-08-02

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Radiology Consultants, Inc. — Youngstown, Ohio, United States

Full record on ClinicalTrials.gov

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