Focal segmental glomerulosclerosis (FSGS) is a condition that harms the kidney "filters" that remove waste from the blood. Proteins are supposed to stay in the blood. Damaged "filters" let protein get into the kidney. FSGS is a serious condition that can lead to kidney failure. The only treatment for kidney failure is dialysis or kidney transplant. Proteinuria means too much protein came through the kidneys into the urine. If the doctor cannot figure out what is causing the problem, it is primary (idiopathic) FSGS. This kind of FSGS is very hard to treat. This study will test Acthar in patients with this condition who have not responded to other treatments. It primarily investigates how well the therapy is tolerated by the patients and how well they respond to this treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Acthar Gel 80 U/mL solution for subcutaneous injection
University of Alabama at Birmingham
Birmingham, Alabama, United States
AKDHC Medical Research Services, LLC
Tucson, Arizona, United States
California Institute of Renal Research
Chula Vista, California, United States
Stanford University
Stanford, California, United States
VERITAS Research Corp
Miami Lakes, Florida, United States
Number of Participants With Adverse Events
Clinically significant changes in laboratory or physical examination findings are counted as adverse events. Descriptive statistics are collected for participants with: 1. death for any reason (all cause mortality) 2. treatment emergent serious adverse events (TESAEs) 3. any non-serious treatment emergent adverse events (TEAEs)
Time frame: within 56 weeks
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Tampa, Florida, United States
GA Nephrology
Lawrenceville, Georgia, United States
NANI Research
Hinsdale, Illinois, United States
University of Louisville Research Foundation, Inc.
Louisville, Kentucky, United States
Ochsner Clinic Foundation, Baton Rouge
Baton Rouge, Louisiana, United States
...and 37 more locations