Sirolimus Treatment Of Patients With SLE

Exclusion Criteria

• •1. Acute SLE flare threatening vital organs;
• •2. Pregnant or lactating;
• •3. Female subjects who are planning to become pregnant during the study or within 3 months after last dosing or male subjects who are considering fathering a child within 3 months after last dosing;
• •4. Abnormal laboratory test results: hemoglobin ≤ 8 g/L (8 g/dL), platelet count ≤ 70 x 109/L (70,000 cells/mm³), white blood cell count ≤ 2.0 x 109/L (2,000 cells/mm³), neutrophils: ≤ 1.5 X 109/L, proteinuria \> 3 g/day measured by 24 hour collection or spot urine protein to creatinine ratio of \>3;
• •5. Glomerular filtration rate (GFR) \< 50 mL/min/1.73 m², any other clinically significant abnormal screening laboratory results as evaluated by the Investigator;
• •6. Moderately serious or serious comorbidities (e.g., diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency) that in investigator's opinion confers high risk for adverse events;
• •7. Patients receiving cyclophosphamide within 3 months;
• •8. Active chronic infections (e.g., HIV, hepatitis B virus, hepatitis C virus, mycobacteria); patients with oral steroid-dependent asthma;
• •9. Infections requiring intravenous antibiotics within a month or oral antibiotics within two weeks of screening;
• •10. Patients taking (unwilling or unable to stop) NAC or other antioxidants within 1 month of screening (which is considered sufficient time to revert GSH to pre-treatment levels;
• •11. Patients receiving rituximab within 12 months or other biologic therapy within five half lives;
• •12. Patients receiving mTOR inhibitors (rapamycin/sirolimus, everolimus);
• •13. Patients enrolled in other interventional trials.