Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection
Withdrawn
- Conditions
- Nephrogenic Systemic FibrosisRenal Insufficiency
- Registration Number
- NCT00811863
- Lead Sponsor
- Guerbet
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Radiology Consultants, Inc.
🇺🇸Youngstown, Ohio, United States