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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811863
Recruitment Status : Withdrawn (Study drug currently unavailable)
First Posted : December 19, 2008
Last Update Posted : August 2, 2017
Information provided by (Responsible Party):

Brief Summary:
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).

Condition or disease
Nephrogenic Systemic Fibrosis Renal Insufficiency

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study for the Detection of Nephrogenic Systemic Fibrosis in Patients With Renal Impairment Undergoing Gadoversetamide-enhanced Magnetic Resonance Imaging
Actual Study Start Date : February 2009
Actual Primary Completion Date : May 17, 2012
Actual Study Completion Date : May 17, 2012

Resource links provided by the National Library of Medicine

Subjects with moderate renal insufficiency defined as an eGFR 30-60 mL/min/1.73 m2
Subjects with severe renal insufficiency defined as an eGFR <30 mL/min/1.73 m2 and ESRD defined as requiring dialysis

Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
Serum; Plasma; Fixed tissue samples

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with moderate to severe renal insufficiency that have been identified as requiring (for any indication) a contrast-enhanced MRI using gadoversetamide.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811863

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United States, Ohio
Radiology Consultants, Inc.
Youngstown, Ohio, United States, 44512
Sponsors and Collaborators
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Study Director: Herbert R. Neuman, MD Mallinckrodt

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Responsible Party: Guerbet Identifier: NCT00811863     History of Changes
Other Study ID Numbers: 1177-07-868
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: August 2017
Keywords provided by Guerbet:
Nephrogenic Systemic Fibrosis
Renal Insufficiency
Magnetic Resonance Imaging
Additional relevant MeSH terms:
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Renal Insufficiency
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Kidney Diseases
Urologic Diseases
Skin Diseases