PROTECT- study of the efficacy and safety of sparsentan for the treatment of Immunoglobulin A (IgAN) nephropathy

Immunoglobulin A nephropathy (IgAN) is a rare disease that affects the kidneys, mostly in teens and adults. Kidneys are important to your health because they filter waste materials such as salts, toxins and water out of the blood. The waste is passed out of your body as urine (pee). IgAN causes damage to the parts of the kidney that filter these waste materials, allowing protein to leak into the urine. The leaking protein is a condition called proteinuria and it causes fluid to build up in the body. If the protein leaks for too long, it can eventually lead to kidney failure (kidneys stop working).

The research team is studying the investigational drug, sparsentan, in patients diagnosed with IgAN. An investigational drug means that not all information is known about how the drug works in your body and it has not yet been approved by the Food and Drug Administration (FDA) for the treatment of IgAN.

The purpose of this study is to learn if sparsentan is safe and effective in lowering the amount of protein in the urine and in preserving kidney function. In this study, sparsentan will be compared to a drug called irbesartan. Irbesartan is approved by the U.S. Food and Drug Administration (FDA), If you are eligible and decide to participate, your involvement in the study may last up to approximately 27 months for the double blind period of the study. Upon Completion of the double blind period and if you agree and are eligble to enter the open-label period the total study participation time is up to 63 months.