Ichihara

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

Researchers are evaluating treatments for newly diagnosed ANCA-associated vasculitis, a serious disease involving inflammation of small to medium blood vessels. This phase 4 trial compares whether avacopan combined with short-term reduced-dose glucocorticoids and rituximab works as well as a longer 20-week reduced-dose glucocorticoid and rituximab treatment for achieving remission. The study also examines if avacopan lowers relapse rates compared to rituximab maintenance therapy and assesses the long-term safety of avacopan. Participants will be randomly assigned to one of two treatment groups. One group receives avacopan with short-term (up to 4 weeks) reduced-dose prednisolone and rituximab given at the start. The other group receives reduced-dose prednisolone for up to 20 weeks combined with rituximab administered at weeks 0, 26, 52, and 78. The study is open-label and will follow patients for up to 104 weeks to compare remission, relapse, and safety outcomes. Patients will be evaluated at multiple time points from baseline through week 104. Assessments include disease status (remission or relapse), disease activity scores, damage indexes, and adverse events. The main outcome is the proportion of patients achieving remission at 26 weeks. Researchers will monitor long-term safety and relapse rates over two years to better understand the benefits and risks of these treatment approaches.