Nephrogenic Systemic Fibrosis, Renal Insufficiency
Conditions
Keywords
Nephrogenic Systemic Fibrosis, Renal Insufficiency, Gadoversetamide, OptiMARK, Magnetic Resonance Imaging
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).
Interventions
None listed
Sponsors
Guerbet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed