Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger

Exclusion Criteria

• •1. Any known gene mutation that causes atypical hemolytic uremic syndrome (aHUS)
• •2. Postpartum aHUS
• •3. Known chronic kidney disease
• •4. TMA due to hematopoietic stem cell transplantation ≤ 12 months of Screening
• •5. Primary and secondary glomerular diseases other than lupus
• •6. Diagnosis of primary antiphospholipid antibody syndrome
• •7. Shiga toxin-producing Escherichia coli infections including but not limited to Shiga toxin-related hemolytic uremic syndrome
• •8. Known familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (ADAMTS13) deficiency (activity \< 5%)
• •9. Positive direct Coombs test which in the judgement of the Investigator is indicative of a clinically significant immune-mediated hemolysis not due to TMA
• •10. Clinical diagnosis of disseminated intravascular coagulation (DIC) in the judgement of the Investigator
• •11. Presence of sepsis requiring vasopressors within 7 days prior to or during Screening
• •12. Presence of monoclonal gammopathy including but not limited to multiple myeloma
• •13. Known bone marrow insufficiency or failure evidenced by cytopenias
• •14. Unresolved N. meningitidis infection
• •15. History of malignancy within 5 years of Screening with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence
• •16. Use of any complement inhibitors within the past 3 years
• •17. Respiratory failure requiring mechanical ventilation