Expired Study
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Youngstown, Ohio 44512


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.

Study is Available At:

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Brief Title:

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

Official Title:

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

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Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:


Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study drug currently unavailable

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Overall Contact Information

Official Name:Herbert R. Neuman, MD
Study Director

Study Dates

Start Date:February 2009
Completion Date:May 17, 2012
Completion Type:Actual
Primary Completion Date:May 17, 2012
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 1, 2017
First Received Date:December 18, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary outcome measure will be the diagnosis of NSF based on clinical assessments and patient telephone calls through 24 months of follow-up.
Time Frame:1, 3, 6, 12, 18 and 24 months
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:Subjects with moderate renal insufficiency defined as an eGFR 30-60 mL/min/1.73 m2
Study Arm Type:Other
Arm Name:2
Description:Subjects with severe renal insufficiency defined as an eGFR <30 mL/min/1.73 m2 and ESRD defined as requiring dialysis

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Guerbet

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Serum; Plasma; Fixed tissue samples
Study Population: Subjects with moderate to severe renal insufficiency that have been identified as requiring (for any indication) a contrast-enhanced MRI using gadoversetamide.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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