Tomigusuku

Researchers are studying primary membranous nephropathy PMN, a kidney condition where harmful autoantibodies build up in the kidney filters, causing damage. This can lead to protein and blood leaking into the urine, swelling, tiredness, and high blood pressure. The study aims to compare how the laboratory-made antibody drug felzartamab works compared to the existing drug tacrolimus in treating PMN, focusing on how many participants achieve complete remission over 104 weeks. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus as oral tablets. Those whose disease worsens or who do not improve may receive additional rescue treatment, including standard immunosuppressive therapy or felzartamab. The study includes an open-label treatment phase and a non-responder treatment phase for those needing rescue therapy. Participants will undergo up to 23 study visits during screening and treatment, which may last up to 104 weeks or 156 weeks if rescue treatment is needed. Researchers will monitor urine protein levels, kidney function, antibody levels, physical health, and side effects. Follow-up visits every 12 weeks will continue if treatment stops early to assess long-term effects and safety.

Researchers are evaluating surgical aortic valve replacement SAVR compared to transcatheter aortic valve replacement TAVR in patients with isolated severe, calcific aortic stenosis who are at low surgical risk. This study, called the AMETHYST trial, aims to determine if SAVR is not worse than TAVR regarding death, stroke, and rehospitalization one year after the procedure. The study is randomized, controlled, and conducted at multiple centers. Participants will be randomly assigned to either receive SAVR, where the surgeon chooses the type of surgical bioprosthetic valve and surgical method, or TAVR, which uses approved transcatheter heart valves available in Japan. The treatments will be delivered according to the assigned group, and patients will be followed for up to 10 years with visits at discharge, 30 days, and annually. During the study, participants will undergo assessments including survival, stroke occurrence, rehospitalization related to valve or heart failure, and heart rhythm changes. Researchers will also evaluate valve function using echocardiography and quality of life through questionnaires at one year. Safety monitoring continues through the long follow-up period. The primary outcome combines death from any cause, stroke, and rehospitalization at one year post-procedure.

Researchers are evaluating the overall survival of patients with stage I epithelial ovarian cancer after they have undergone comprehensive staging surgery. This phase III trial compares the outcomes of adjuvant chemotherapy versus observation alone. The study aims to determine whether adding chemotherapy after surgery improves survival in this patient group. Participants will be randomly assigned to one of two groups. One group receives adjuvant chemotherapy, which includes either a combination of paclitaxel and carboplatin or docetaxel and carboplatin, given every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. The other group undergoes observation without chemotherapy. During the study, participants will be monitored for overall survival up to 60 months from randomization. Researchers will also assess relapse-free survival within the same timeframe. Evaluations include follow-ups to track disease progression, side effects, and general health. The study ensures participants receive appropriate care and measures outcomes to better understand treatment benefits and risks.

Researchers are evaluating an experimental drug called REGN7508 in adults undergoing elective, unilateral total knee replacement surgery. The study aims to assess how well REGN7508 prevents venous thromboembolism VTE and related conditions following surgery. It also investigates potential side effects, the levels of the drug in the blood over time, and the bodys antibody response to the drug. Participants in this phase 3 trial receive one of several treatments REGN7508 alone, REGN7508 with placebo, apixaban, or enoxaparin, all administered according to protocol. The study uses a randomized, parallel design with double blinding to compare these treatments. The treatment period focuses on the first 12 days after surgery, with extended monitoring up to approximately 90 days to assess drug concentration and antibody formation. During the study, participants will undergo assessments including monitoring for symptomatic and asymptomatic VTE events, bleeding incidents, and adverse events up to day 90. Blood tests will measure drug levels and antibodies against REGN7508. Safety and effectiveness outcomes are tracked closely with visits approximately 14 days post-surgery for primary measures and follow-up assessments around day 90. Total participation lasts through the treatment and extended safety evaluation period.