Ichihara

Researchers are evaluating DMX-200 repagermanium, a drug that blocks a receptor involved in inflammation, in patients with focal segmental glomerulosclerosis FSGS who are also receiving an angiotensin II receptor blocker ARB. This Phase 3 study aims to assess the safety and effectiveness of DMX-200 compared to placebo over two years in adults and adolescents aged 12 to 17 years. The study is led by Dimerix Bioscience Pty Ltd and includes a double-blind period followed by an open-label extension to observe long-term effects. Participants receive either 120 mg of DMX-200 or a matching placebo capsule twice daily for 104 weeks during the double-blind treatment phase. Afterward, those who complete this phase may enter a two-year open-label extension where all participants receive DMX-200 twice daily. The study includes a screening and qualification period lasting 6 to 14 weeks, a possible titration phase, a stabilization phase, and a follow-up period after treatments. Throughout the trial, patients will undergo assessments including urine proteincreatinine ratio and kidney function tests like estimated glomerular filtration rate eGFR at multiple time points up to week 104 and during the extension. Safety and tolerability are closely monitored through regular evaluations, adverse event tracking, and follow-up visits. Total participation may last about 230 weeks, covering all study phases and follow-up periods.

Researchers are investigating the treatment of newly diagnosed ANCA-associated vasculitis, a serious condition affecting small- to medium-sized blood vessels. This phase 4 trial compares the effectiveness and safety of avacopan combined with short-term reduced-dose glucocorticoids and rituximab versus a longer course of reduced-dose glucocorticoids with rituximab. The study aims to understand if avacopan can achieve similar remission rates and reduce relapse compared to current therapies, while also assessing long-term safety. Participants will be randomly assigned to one of two treatment groups. One group receives avacopan daily along with a 4-week reduced-dose prednisolone course and rituximab infusions. The other group receives reduced-dose prednisolone tapered over 20 weeks plus rituximab infusions at scheduled times. Both groups have options for short-term rescue prednisolone if needed. Maintenance therapy continues with either avacopan or rituximab at regular intervals up to 24 months. Throughout the 104-week study, participants will be evaluated at multiple timepoints for disease activity, remission status, relapse, organ damage, and any adverse events. Assessments include standardized vasculitis activity scores and damage indices, quality of life questionnaires, and monitoring for side effects such as infections and new medical conditions. The main outcome measured is the proportion of patients achieving remission at 26 weeks, with ongoing follow-up to observe relapse rates and long-term safety.