Clinical Research Studies

Chronic kidney disease (CKD) has become a worldwide public health issue due to its high incidence, poor prognosis, and substantial economic burden. When not properly diagnosed and managed, CKD can lead to many adverse outcomes such as end-stage renal disease (ESRD). Despite advances in immunosuppressive treatments, certain types of glomerulonephritis such as lupus nephritis (LN) and immunoglobulin A nephropathy (IgAN) continue to respond poorly to treatment, resulting over time in CKD. No disease-specific therapies are currently available, therefore effective treatments for managing LN and IgAN represent a high unmet medical need. The pathophysiology of glomerular diseases such as LN and IgAN involves a complex overlap of abnormal cellular immune response, loss of humoral immune tolerance, aberrant coagulation, and systemic inflammation. Complement dysregulation has emerged as an additional driving factor that interplays with these pathways in LN and IgAN. The narrow vessels and high perfusion in the kidney make this organ particularly susceptible to complement-mediated injury. Histologic evidence of complement deposition observed upon kidney biopsy of patients with either LN or IgAN suggests a pathological role. This theory is supported by the association of serum complement levels with disease activity and response to treatment, particularly in patients with LN. The objectives of this study are to evaluate the safety and efficacy of ravulizumab (ULTOMIRIS®) administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN or IgAN.