This is an open label safety and feasibility trial using Acthar® in addition to center-specific standard therapy including plasma exchange, for treatment of post transplant recurrent FSGS and post transplant recurrent idiopathic membranous nephropathy. Subjects will receive Acthar® 40 units subcutaneously (SC) twice weekly for two weeks then 80 units SC twice weekly for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Agent Dose Route Schedule H.P. Acthar Gel 40 units SC twice weekly\* Weeks 1 and 2 H.P. Acthar Gel 80 units SC twice weekly\* Weeks 3 through 24 H.P. Acthar Gel 80 units SC once weekly\* Weeks 25 through 26 H.P. Acthar Gel 40 units SC once weekly\* Weeks 27 through 28 \*Injections are to be spaced 72-96 hours apart (+/-6 hours).
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
number of patients with proteinuria
partial and complete remission of proteinuria
Time frame: 24 and 52 weeks
Graft loss
graft loss defined by return to dialysis, re-transplant or death during study period
Time frame: during study period
eGFR change
estimated Glomerular filtration rate (eGFR MDRD formula) change from baseline
Time frame: weeks 4,8,12,16,20 and 24
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