SLE Glomerulonephritis Syndrome, WHO Class V Clinical Trial
Official title:
An Open Label Randomized Phase IV Study of the Safety and Efficacy of ACTHAR GEL in Patients With Membranous (Class V) Lupus Nephritis
This is an open-label, randomized, multi-center, Phase IV study of Acthar Gel in patients
with biopsy-proven membranous (Class V) lupus nephritis (LN) aimed at providing
proof-of-concept data that Acthar is a safe and effective therapy for membranous LN. Class V
LN is a secondary form of membranous nephropathy, and occurs in 8-20% of patients with LN.
Two different doses of Acthar Gel will be tested. The active intervention phase of this study
will take place over 6 months, and follow-up will occur over the following 6 months. Efficacy
and safety of the use of Acthar Gel for treatment of membranous LN will be assessed and
analyzed throughout the course of the study by laboratory testing, physical exams, and other
evaluation tools. Subjects will be closely monitored for adverse effects associated with the
use of Acthar gel and if necessary study drug dosing will be reduced. The anticipated
benefits to subjects are a complete renal response rate of 40% at 6 months showing
superiority over the published complete remission rates of the currently used
immunosuppressive therapies, and no unexpected toxicity signals.
Pure Class V LN affects a significant number of systemic lupus erythematosus (SLE) patients
and although it is less aggressive than proliferative forms of LN it still causes important
renal and non-renal morbidity and mortality over time, especially in patients who remain
nephrotic. The therapy of Class V LN is not clear, and currently used therapies are highly
toxic because of immunosuppression, risk of infertility, and risk of future malignancy.
Additionally, these therapies are only modestly effective in inducing remissions of Class V
LN. There is thus an unmet need for a more effective and less toxic treatment for Class V LN.
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