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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-05-17

Brief Summary

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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).

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Detailed Description

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Conditions

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Nephrogenic Systemic Fibrosis Renal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects with moderate renal insufficiency defined as an eGFR 30-60 mL/min/1.73 m2

No interventions assigned to this group

2

Subjects with severe renal insufficiency defined as an eGFR \<30 mL/min/1.73 m2 and ESRD defined as requiring dialysis

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No