The purpose of this research study is to determine if the study drug H.C. Acthar gel slows the progression of your kidney disease. This drug is a steroid-based medicine with fewer side effects than other steroids used for treatment of kidney diseases similar to APOL1 nephropathy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
FDA approved drug being used in this study for sub-nephrotic proteinuria. Given Investigational New Drug (IND) exemption by FDA.
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Change in proteinuria with H.C. Acthar gel
Complete remission (CR) (UPCR \<0.2g/g) or partial remission (PR) (50% drop in UPCR from baseline) of proteinuria at the end of Treatment period in patients with baseline nephrotic proteinuria
Time frame: End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)
Change in proteinuria with H.C. Acthar gel
Percent change in proteinuria at the end of Treatment period in patients with baseline sub-nephrotic proteinuria
Time frame: End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)
Change in eGFR with H.C. Acthar gel
Percent change in Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR at the end of Treatment period
Time frame: End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)
Percent change in proteinuria
Percent change in proteinuria after 1 year and 2 years of follow-up
Time frame: 1 year and 2 years of study follow-up after treatment completion
Percent change in CKD-EPI eGFR
Percent change in CKD-EPI eGFR at 1 and 2 years of study follow-up
Time frame: 1 year and 2 years of study follow-up after treatment completion
Change in CKD-EPI eGFR
Change in eGFR over time, based on baseline proteinuria (nephrotic vs. sub-nephrotic), baseline eGFR (eGFR 30-45 vs. eGFR 45-59), and Acthar dose
Time frame: 1 year and 2 years of study follow-up after treatment completion
Duration of remission after H.C. Acthar gel treatment
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Proportion of patients with baseline nephrotic proteinuria who sustained CR or PR at 1 and 2 years of study follow-up
Time frame: 1 year and 2 years of study follow-up after treatment completion
Changes in kidney fibrosis after H.C. Acthar gel treatment
Modifications in kidney histopathology on second post-treatment kidney biopsy (% glomerulosclerosis, % tubulointerstitial fibrosis, restoration of podocyte markers \[e.g.,podocin, synaptopodin, Wilms tumor 1\]) compared with baseline biopsy
Time frame: End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)
Cholesterol and lipoprotein profile before and after treatment with H.C. Acthar gel
Changes in cholesterol and lipoprotein levels compared with baseline profiles
Time frame: End of treatment with H.C. Acthar gel (end of 6 months or 1 year of treatment)