Phase 3 Study of Ravulizumab Infusions for Children Aged 2 to Under 18 with Primary Immunoglobulin A Nephropathy

What this Trial Is About

Researchers are evaluating the pharmacokinetics, pharmacodynamics, safety, and effectiveness of ravulizumab given by intravenous infusion in children aged 2 to less than 18 years who have primary Immunoglobulin A Nephropathy IgAN or Immunoglobulin A Vasculitis Associated Nephritis IgAVN. This Phase 3, open-label study aims to better understand how the drug behaves in the body and its impact on the condition in pediatric patients. All participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by weight-based maintenance doses on Day 15 and then either every 8 weeks or every 4 weeks depending on their weight. This dosing schedule continues through the study period. The study is designed as a single-group trial where all children receive the investigational drug intravenously. During the study, participants will be closely monitored with assessments including urine protein to creatinine ratio UPCR to measure proteinuria, blood tests to evaluate serum complement levels and drug concentrations, and kidney function tests such as estimated glomerular filtration rate eGFR. Safety monitoring includes tracking adverse events and antibody development against ravulizumab. The primary outcome focuses on changes in proteinuria at Week 34, with ongoing follow-up up to Week 106. The total participation duration spans over two years, ensuring thorough evaluation of treatment effects and safety.

Study of Ravulizumab in Pediatric Participants With Primary IgAN