Kawara

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 the efficacy, safety, and tolerability of povetacicept in adults with primary membranous nephropathy (pMN), a kidney condition confirmed by biopsy. This study is a Phase 2b/3 adaptive, randomized, active-controlled trial comparing povetacicept with a calcineurin inhibitor treatment. Participants will receive either povetacicept, given as a solution for subcutaneous injection, or tacrolimus capsules taken orally. The study aims to compare these treatments in managing pMN over the course of the trial. Throughout the study, researchers will monitor participants for the proportion who achieve complete clinical remission by Week 104. Safety, tolerability, and other clinical outcomes will also be assessed to understand the treatments' effects over time.

Researchers are evaluating the effects 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 includes participants with Grades 1, 2, or 3 chondrosarcoma who are not eligible for curative surgery and have experienced disease progression or recurrence. The study focuses on participants who have received zero or one prior systemic treatment in the advanced or metastatic setting. The main goal is to measure progression-free survival in participants with Grade 1 and 2 tumors. Participants who qualify will be randomly assigned in a 1:1 ratio to receive either oral ivosidenib 500 mg once daily, given as two 250 mg tablets, or a matching placebo once daily. The treatment period will continue until disease progression or unacceptable side effects occur. The study assesses the therapy's impact on disease control compared to placebo in this patient population. During the study, participants will undergo regular imaging assessments to track tumor size and progression according to standardized criteria. IDH1 mutation status is confirmed centrally before enrollment. Researchers will monitor progression-free survival as the primary outcome and also evaluate overall survival. Safety and recovery from prior treatments will be closely observed throughout the trial, which may last up to approximately 31 months for the main outcome assessment.

Researchers are evaluating whether adding preoperative chemotherapy before surgery improves outcomes for patients with high-risk dedifferentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) located in the retroperitoneal or pelvic areas. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to increase disease-free survival in these patients. High-risk tumors are carefully defined by specific pathological and imaging criteria to select appropriate participants. Participants are randomly assigned to one of two groups. The standard group undergoes large, en-bloc curative surgery within four weeks of randomization. The experimental group receives three cycles of chemotherapy—doxorubicin plus ifosfamide for high-grade liposarcoma, or doxorubicin plus dacarbazine for leiomyosarcoma—starting within two weeks after randomization. After chemotherapy, operability is reassessed and surgery is performed within three to six weeks following the last chemotherapy cycle. Chemotherapy doses may be adjusted according to guidelines but must meet minimum thresholds. During the study, patients undergo imaging to measure their tumors and provide tumor tissue and blood samples for pathology and research. Eligibility includes performance status, organ function, and use of effective birth control for those of reproductive potential. Researchers monitor disease-free survival over seven years from the first patient's enrollment. Safety, treatment response, and other health assessments are part of the follow-up during and after treatment.