In this study we want to learn if a drug called ravulizumab is a safe and effective treatment for children and teens that have both Immunoglobulin A Vasculitis Nephritis (IgAVN) and Immunoglobulin A Nephritis (IgAN).
The study drug, ravulizumab, is not yet approved to treat IgAVN and IgAN in children. This means it is investigational. If you or your child joins this study, you will come to 30 study visits at Children's Hospital Colorado over about two years. At study visits we will do brief physical exams and ask you or your child questions about your health. We will use a needle in your or your child's arm to take blood samples. We will also ask you or your child to give urine samples. We will do ECGs to see how you or your child's heart is beating. The study drug will be given as an infusion through an IV at certain study visits. You or your child will be paid for the study visits you take part in. If needed, you also may be paid back for travel costs, like parking or a hotel.
You or your child may be able to join this study if you are between 2 and 18 years old and have a diagnosis of Immunoglobulin A Vasculitis Nephritis (IgAVN) and Immunoglobulin A Nephritis (IgAN). You or your child may also be able to join if you weigh at least 10 kilograms. You or your child must have been taking a stable dose of an ACE inhibitor or ARB drug for at least three months before joining the study. You or your child cannot join the study if you have had a bone marrow transplant or certain types of organ transplants. Before joining, a study doctor will do other tests to make sure you meet all of the requirements and it is safe for you to join.
Protocol Number: 25-0559
Principal Investigator