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

Renal Insufficiency Clinical Trial

— SHERLOC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00811863
• Other study ID #: 1177-07-868
• Status: Withdrawn
• Phase: N/A
• First received: December 18, 2008
• Last updated: August 1, 2017
• Start date: February 2009
• Est. completion date: May 17, 2012

Study information

• Verified date: August 2017
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 17, 2012
• Est. primary completion date: May 17, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Nephrogenic Fibrosing Dermopathy
• Nephrogenic Systemic Fibrosis
• Renal Insufficiency

Locations

Country	Name	City	State
United States	Radiology Consultants, Inc.	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

United States, 

Outcome

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