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

NCT00811863 | Withdrawn

• 1 other identifier: 1177-07-868
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Nephrogenic Systemic Fibrosis; Renal Insufficiency

Keywords

Nephrogenic Systemic Fibrosis; Renal Insufficiency; Gadoversetamide; OptiMARK; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (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.

  1, 3, 6, 12, 18 and 24 months

Study Arms (2)

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (1)

Radiology Consultants, Inc.

Youngstown, Ohio, 44512, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum; Plasma; Fixed tissue samples

MeSH Terms

Conditions

Nephrogenic Fibrosing Dermopathy; Renal Insufficiency

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Herbert R. Neuman, MD

  Mallinckrodt

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: February 1, 2009
• Primary Completion: May 17, 2012
• Study Completion: May 17, 2012
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

US (1)