We want to learn if ravulizumab can help slow down or stop kidney problems and lower protein in the urine. We will also compare ravulizumab to a placebo (a substance with no medicine) to see how well it works.
If you are interested in this study, you will first have a visit to see if you qualify. At this visit, the doctor will do tests to see if you can join. This includes a physical exam, a heart test (called ECG), and questions about your health and medicines. We will also take a small amount of blood and urine from you to make sure it is safe for you to join the study. You might need a kidney biopsy if you don’t have one. If you qualify and want to join, you will start the study which lasts about 2 years. You will have visits every 8 weeks to get the medicine through an IV and have more tests and exams. Some people will get the real medicine, and some will get a placebo. A placebo looks the same and is given the same as the medicine being studied but has no active ingredients. After the study is over, you can choose to join an extra 2-year period to keep getting the medicine and visiting the clinic. The whole study, including screening, treatment, and extra time, could take up to 4 years. Each visit takes about 3 to 4 hours. All study tests, visits, and medicine are at no cost to you. You may also get paid for your time and travel—up to $74 for visits without urine tests and up to $111 for visits with urine tests.
To join, you must be an adult diagnosed with IgA nephropathy (IgAN) from a kidney biopsy. This biopsy can be done before or during the first visit. Your urine must have a high amount of protein, shown by either a urine protein-to-creatinine ratio (UPCR) of 0.75 or more, or at least 1 gram of protein in a full day’s urine collection during the first visit. Your kidney function, measured by a test called eGFR, should be at least 30 mL per minute for most people. For people with an eGFR between 20 and 29, you will need to have had a kidney biopsy within 6 months before the first visit or during screening. The report must show less than 75% damage to certain parts of the kidney. Your urine must also show blood, either by a positive dipstick test or by seeing 5 or more red blood cells under a microscope, during or within 3 months before screening.
Protocol Number: 24-0436
Principal Investigator