Dr. Rex Ochi, a nephrologist at The Polyclinic Madison Center, is currently conducting a Phase 3 clinical study testing the safety and effectiveness of an investigational drug called OMS721 designed to treat Immunoglobulin A Nephropathy (IgAN). This study will see if OMS721 can reduce proteinuria while maintaining stable kidney function in people with IgAN.
IgAN occurs when a protein called Immunoglobulin A (IgA) gets stuck in the kidneys. This causes an inflammation of the kidney’s filtering units, called glomeruli. When glomeruli become inflamed, they begin to lose their function, and important proteins start leaking into the urine (proteinuria). The goal in treating IgAN is to stop or lower the amount of protein lost in the urine. There are currently no FDA approved treatments for IgAN.
About the Study Drug
To date, OMS721 has been evaluated in healthy volunteers, people with kidney diseases (including 19 people with IgAN) and people with thrombotic microangiopathies (TMA). OMS721 has been well tolerated by participants and side effects have been generally mild or moderate. Based on these positive results, OMS721 in IgAN received a breakthrough therapy designation from the FDA. This means that FDA approval can be obtained if a Phase 3 study can demonstrate that OMS721 effectively reduces proteinuria.
This study is open to individuals who are 18 years or older and have been diagnosed with IgAN. All study visits will take place at The Polyclinic Madison Center. Study treatment will be administered via intravenous infusion (IV) once a week for 12 weeks. Depending on your response, you may be eligible to receive re-treatment.
There is no cost to participate in the study. Study treatment and all tests and procedures associated with the study are provided at no cost to you. You will receive financial compensation for your time and effort.
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