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

This study has suspended participant recruitment.
(Study drug currently unavailable)
Sponsor:
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00811863
First received: December 18, 2008
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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
Nephrogenic Systemic Fibrosis
Renal Insufficiency

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Serum; Plasma; Fixed tissue samples


Estimated Enrollment: 1000
Study Start Date: February 2009
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects with moderate renal insufficiency defined as an eGFR 30-60 mL/min/1.73 m2
2
Subjects with severe renal insufficiency defined as an eGFR <30 mL/min/1.73 m2 and ESRD defined as requiring dialysis

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811863

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

No publications provided

Responsible Party: Eddie Darton, MD, Mallinckrodt
ClinicalTrials.gov Identifier: NCT00811863     History of Changes
Other Study ID Numbers: 1177-07-868
Study First Received: December 18, 2008
Last Updated: March 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Nephrogenic Systemic Fibrosis
Renal Insufficiency
Gadoversetamide
OptiMARK
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Fibrosis
Renal Insufficiency
Renal Insufficiency, Chronic
Nephrogenic Fibrosing Dermopathy
Pathologic Processes
Kidney Diseases
Urologic Diseases
Skin Diseases
Gadoversetamide
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014