ACTHAR GEL in Patients With Membranous (Class V) Lupus Nephritis

Exclusion Criteria

• •Patients \< 18 years of age
• •* Pregnancy or planning to become pregnant anytime throughout their participation in the trial, up until 30 days after last dose of study drug.
• •* Kidney biopsy with active Class III or IV LN
• •* More than 50% interstitial fibrosis and/or glomerulosclerosis on kidney biopsy
• •* Patients with hepatitis B, C, HIV, TB or other active and chronic infections at the time of screening
• •* Patients with liver disease and transaminases greater than 2.5 times the upper limit of normal of the laboratory, patients with diabetes mellitus type I or II, patients with refractory hypokalemia, patients with Cushing's Disease or Syndrome
• •* Patients who have been treated with cyclophosphamide, cyclosporine A, tacrolimus, B-cell depleting therapies, or experimental therapies including biologics within 6 months of screening
• •* Patients with active neuropsychiatric lupus, lupus pneumonitis, lupus vasculitis at screening
• •* Patients with high or very high extra-renal lupus activity defined as an xSLEDAI score greater than 10 at the time of screening
• •* Patients who have received high-dose intravenous methylprednisolone (1 g cumulative) within 3 months of screening
• •* Patients currently receiving, or who have received MMF or AZA in the 3 months preceding enrollment for extra-renal SLE.
• •* Patients who have received methotrexate or who are receiving methotrexate and it can be discontinued will be eligible; if methotrexate cannot be stopped safely, the patient will not be eligible.
• •* Patients currently receiving more than 20 mg/d prednisone that cannot be safely reduced to 20mg/d or less beginning at least one month before enrollment on day 0
• •* Patients who are not on a stable dose of Anti-Malarials and/or Anti-hypertensives at least one month preceding baseline visit and during the study. (Refer to allowed medication section)