The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks
Unnamed facility
New Hyde Park, New York, United States
Unnamed facility
Chapel Hill, North Carolina, United States
Unnamed facility
Columbus, Ohio, United States
Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications
Time frame: 32 weeks
Standard plasma and urinary PK parameters
Time frame: 32 weeks
Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids
Time frame: 8 weeks
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