Komae

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

This clinical trial is studying adults who have experienced a small ischemic stroke, also known as lacunar stroke. It aims to determine if a combination of antiplatelet drugs dual antiplatelet therapy works as well as the standard treatment with intravenous tissue plasminogen activator rt-PA. Researchers also want to see if the combination reduces bleeding complications compared to rt-PA. Participants will be randomly assigned to receive either the dual antiplatelet therapy, which includes aspirin 200 mg and clopidogrel 300 mg, or intravenous rt-PA at a low dose of 0.6 mgkg alteplase, which is approved in Japan. The study follows a parallel design and is conducted at multiple centers. Treatment is given during the hyperacute phase within 4.5 hours of stroke onset. During the study, participants will be monitored for neurological status at 3 months after stroke through in-person visits, phone calls, or mail. Researchers will measure outcomes such as excellent recovery at 3 months, infarct growth, early neurological changes, stroke recurrence, and cost effectiveness. The total study period extends through March 2029, with primary outcome assessment at 3 months post-stroke.