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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The Ohio State University Wexner Medical Center, Nephrology Clinical Trials Unit
Columbus, Ohio, United States
Number of participants with adverse events
Measuring adverse events and serious adverse events taking Acthar Gel in Class V lupus nephritis
Time frame: Baseline and Month 12
Change in laboratory data
changes in laboratory parameters, and metabolic side effects such as hyperglycemia, hypokalemia, and hyperlipidemia
Time frame: Baseline and Month 12
Renal Response to Acthar Gel
Change in Proteinuria and serum creatinine
Time frame: Baseline and Month 6
Change in remission
To determine the duration of complete and partial remission after study drug is stopped
Time frame: Month 6 and Month 12
Change baseline SLE laboratory
To determine the effect of Acthar Gel on baseline levels of anti-double stranded DNA (dsDNA) antibodies and complement components C3 and C4
Time frame: Baseline and month 6
Change in extra-renal systemic lupus erythematosus disease activity index
To determine the effect of Acthar Gel on the patients global assessment score, the physicians global assessments score and xSLEDAI
Time frame: Baseline and Month 6
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