Kawara

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 studying the effects of povetacicept in adults with primary membranous nephropathy pMN, a kidney condition. This study aims to evaluate how well povetacicept works, its safety, and how well patients tolerate it compared to another treatment called tacrolimus. The trial includes adults aged 18 to 75 years and is conducted by Vertex Pharmaceuticals Incorporated. Participants will be randomly assigned to receive either one of two doses of povetacicept, which is given as a solution for subcutaneous injection, or tacrolimus capsules taken orally. The dosing for povetacicept is based on previous phase 2b results. This study follows a sequential design and is conducted in phases 2 and 3. During the study, researchers will monitor participants for clinical remission of their kidney disease at 104 weeks. They will also track safety by recording adverse events up to week 112. Participants will have scheduled visits to assess their condition and treatment response. The total study duration extends up to nearly four years, concluding in late 2028.

Researchers are evaluating the use of oral ivosidenib in adults with locally advanced or metastatic conventional chondrosarcoma that has an IDH1 gene mutation. This Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study focuses on participants who have not had curative surgery and have experienced disease progression or recurrence. Participants may have had up to one prior systemic treatment for their advanced or metastatic chondrosarcoma. The study aims to measure progression-free survival as the primary outcome, especially in Grades 1 and 2 patients, along with overall survival and other efficacy and safety outcomes. Participants will be randomly assigned to receive either ivosidenib 500 mg orally once daily as two 250 mg tablets or a matching placebo. Treatment will continue until disease progression confirmed by blinded independent central review, unacceptable side effects, pregnancy, death, withdrawal, loss to follow-up, or study end, with an expected average treatment duration of about two years. Those on placebo who experience disease progression and meet criteria may cross over to receive ivosidenib. Throughout the study, participants will undergo regular imaging assessments to monitor tumor response using RECIST v1.1 criteria. Various patient-reported outcomes, adverse event monitoring, and laboratory tests including plasma ivosidenib and 2-hydroxyglutarate levels will be collected. The study includes follow-up for up to 5 years to evaluate long-term survival, disease control, and safety. The total participation duration varies depending on individual progression and study timelines.

Researchers are evaluating whether adding chemotherapy before surgery can improve outcomes for patients with high-risk dedifferentiated liposarcoma DDLPS and leiomyosarcoma LMS in the retroperitoneal area. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to improve disease-free survival for these patients. The study is randomized and open-label, involving multiple centers. Participants are randomly assigned to one of two groups. The standard group undergoes large curative surgery within four weeks after randomization. The experimental group receives three cycles of chemotherapy tailored to their sarcoma typedoxorubicin and ifosfamide for high-grade liposarcoma, or doxorubicin and dacarbazine for leiomyosarcomastarting within two weeks of randomization, followed by a reassessment and surgery within three to six weeks after the last chemotherapy cycle. During the study, patients are closely monitored through imaging and pathology reviews to confirm tumor characteristics and treatment effects. Researchers measure disease-free survival over seven years, along with overall survival, recurrence rates, response to chemotherapy, side effects, complications, and quality of life for up to eight years. Participants provide tumor tissue and blood samples for research, and their health and safety are carefully tracked throughout the study period.