Description
Inclusion Criteria:
- * Age ≥ 18 years of age.
- * Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria.
- * Renal biopsy confirming the diagnosis of active class III/IV (± class V) LN (based on International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003) within 12 months of enrollment.
- * Proteinuria ≥ 500 mg over 24 hours.
- * eGFR ≥ 30 ml/min/SA.
- * Subjects should be able to give informed consent.
Exclusion Criteria:
- * Pregnancy.
- * Hepatitis B or C, HIV
- * Anemia with Hgb \< 8.0 g/dL.
- * Thrombocytopenia with platelet count \< 100'000.
- * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.
- * Unable to provide consent.
- * Patients receiving \> 10 mg of oral prednisone or glucocorticoid equivalent if on corticosteroids for \> 2 weeks (patients would be allowed to be on \> 10 mg of prednisone or its oral equivalent as long as the duration is ≤ 2 weeks).
- * Patients who had received immunosuppressive therapy including cyclosporine, tacrolimus or azathioprine in the last 3 months.
- * Patients who have received cyclophosphamide in the last 6 months.
- * Patients who received rituximab previously with CD20 count of zero at the time of enrollment.
- * Patient are allowed to be on MMF at time of enrollment but no higher than total of 1500mg/day.
- * For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 12 months after the last dose of study drug.
- * For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period.
- * Patients with diagnosis of glaucoma.
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No