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

This is an interventional treatment trial for SLE Glomerulonephritis Syndrome, WHO Class V Read More

Inclusion Criteria:

• Patients ≥ 18 years of age who have pure Class V LN or Class V+II LN diagnosed by a kidney biopsy within 4 months of screening. If a patient has segmental glomerular scarring indicative of previous Class III or IV lesions, but no evidence of current Class III or IV activity, and only the Class V component is active, they can be enrolled, despite having a mandatory ISN/RPA classification of Class V + III or IV
• Proteinuria ≥ 3 g/d despite adequate blood pressure control defined as systolic blood pressure ≤ 130 mm Hg 75% of the time, per the clinical judgment of the site investigator.
• Serum creatinine < 2 mg/dl or eGFR > 30 ml/minute

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)