Tochigi

Researchers are evaluating the safety and effectiveness of two combined treatments, KarXT and KarX-EC, for adults aged 55 to 90 who experience agitation related to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to better understand how these treatments may help reduce agitation symptoms in this population while monitoring safety. Participants will receive either the active drugs Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule or a placebo, taken at specified doses on designated days. The study is carefully designed to compare these treatments against placebo to evaluate their impact on agitation symptoms associated with Alzheimer's Disease. During the study, participants will be assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score to measure changes from baseline at Week 14. Caregivers will be involved to help monitor compliance and report participant status throughout the study. Safety and efficacy will be closely monitored during this 14-week period to gather detailed information about treatment outcomes.

Researchers are evaluating the effectiveness of anitocabtagene autoleucel compared to standard of care therapy in adults with relapsed or refractory multiple myeloma who have previously received one to three treatments, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The study is a Phase 3, randomized, open-label trial aiming to assess how well anitocabtagene autoleucel works versus existing therapies in this patient group. Participants will receive either a single infusion of anitocabtagene autoleucel, which is a CAR+ transduced autologous T cell therapy, or one of several standard of care treatments. The standard treatments include combinations involving drugs such as pomalidomide, bortezomib, dexamethasone, daratumumab, carfilzomib, cyclophosphamide, and fludarabine, administered either orally or intravenously/subcutaneously. After the treatment period, those receiving anitocabtagene autoleucel will enter a follow-up phase and then transition to a long-term follow-up study lasting up to 15 years. During the study, participants will be monitored for progression-free survival for up to four years and for minimal residual disease complete response rate at nine months. Researchers will assess disease progression, treatment safety, and other health markers. Follow-up includes regular evaluations to track the participant's response and overall health status, with continued long-term monitoring planned for those treated with anitocabtagene autoleucel.

Researchers are evaluating the effectiveness, safety, and behavior of a new treatment called sefaxersen (RO7434656), an Antisense Oligonucleotide (ASO) therapy, for people with primary IgA nephropathy (IgAN). The study focuses on participants who have a high risk of their kidney disease worsening despite receiving the best available supportive care. This is a Phase III, randomized, double-blind, placebo-controlled trial conducted at multiple centers. Participants will receive either sefaxersen or a matching placebo through subcutaneous injections according to a specified schedule. The study compares these two groups to see how the treatment affects kidney function over time. The intervention is designed to inhibit Complement Factor B, which is involved in the disease process. The study includes vaccination requirements and contraceptive use for women of childbearing potential to ensure safety. During the study, participants will be monitored for changes in their urine protein-to-creatinine ratio (UPCR) at baseline and at week 37, which is the primary measure of kidney function improvement. Other assessments include kidney biopsy results, kidney function tests estimating glomerular filtration rate (eGFR), and ongoing safety evaluations. The trial tracks participants' health closely to assess the treatment's effect and any side effects throughout the study period.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the safety and clinical effects of Awiqli (Insulin Icodec) in people with diabetes mellitus in Japan during routine clinical care. This study aims to understand how Awiqli works and how safe it is when used in real-world medical settings. Both men and women of any age with a diabetes diagnosis can participate, and the study will last about one year. Participants will receive Awiqli as prescribed by their treating doctor according to usual medical practice. The treatment involves using commercially available Awiqli once weekly. This is a single-group, open-label, non-interventional study, meaning there is no placebo or comparison group and the treatment is given as part of normal care. Throughout the 52-week study, researchers will collect data on any adverse reactions from the start until the end of the study. Participants will be monitored for safety and clinical outcomes as they use Awiqli. The study includes regular follow-up to assess treatment effects and collect safety information over the full year.

Researchers are evaluating the safety and effectiveness of peficitinib in patients with rheumatoid arthritis (RA) receiving treatment in routine clinical practice. This mandatory Post-Marketing Surveillance (PMS) study is conducted as part of the Japan Risk Management Plan (J-RMP) and requested by the Pharmaceuticals and Medical Devices Agency (PMDA). The aim is to collect real-world data on patients treated with peficitinib for RA. The study involves treatment with oral peficitinib, given as part of routine clinical care. There are no comparator groups; all participants will be patients receiving peficitinib for the first time. The study focuses on monitoring safety and effectiveness in an actual clinical setting without altering the standard treatment schedule. Participants will be followed for up to 156 weeks to assess safety outcomes such as the frequency of adverse events, serious infections, malignancies, and events leading to death. Effectiveness will be measured up to 52 weeks using disease activity scores including DAS28 (using C-reactive protein and erythrocyte sedimentation rate), Simplified Disease Activity Index, Clinical Disease Activity Index, tender and swollen joint counts, and global assessments by patients and physicians. Researchers will also evaluate EULAR response criteria and remission rates. This long-term follow-up provides comprehensive safety and effectiveness data in real-world RA treatment.

Researchers are investigating whether a combination of antiplatelet drugs works as well as intravenous tissue plasminogen activator (rt-PA) in treating small ischemic strokes known as lacunar strokes. This phase 4 trial aims to determine if the dual antiplatelet therapy is not inferior to the current standard rt-PA treatment and if it reduces bleeding complications compared to rt-PA. Participants will receive either a low-dose rt-PA treatment (0.6 mg/kg alteplase) or a dual antiplatelet therapy consisting of aspirin 200 mg and clopidogrel 300 mg. Treatment is given during the hyperacute phase of stroke, within 4.5 hours of symptom onset. The study compares these two approaches to assess their effectiveness and safety. During the study, participants will be monitored for neurological status three months after their stroke. Assessments may be conducted in person, by phone, or by mail. The main outcome measured is the proportion of participants achieving an excellent outcome three months post-stroke. Safety and treatment effects will be closely observed throughout the trial.

Researchers are evaluating the safety and effectiveness of two different treatment intensities of continuous kidney replacement therapy in critically ill patients with acute kidney injury. This study compares low-intensity therapy (12 mL/kg/hr) to medium-intensity therapy (25 mL/kg/hr) to determine which approach is better for managing this condition. The trial is a multicenter, randomized clinical study involving adults admitted to intensive care units who require such kidney support. Participants will receive either low-dose or standard-dose continuous hemodialysis and/or hemofiltration using dialysate and filtration replacement fluids. The treatment intensity is defined by the dose of therapy administered continuously. The study focuses on these two dosing strategies to assess their impact on patient outcomes. During the trial, researchers will monitor participants for a composite outcome of death and the duration of kidney replacement therapy over 28 days or until hospital discharge, whichever occurs first. Patients will be assessed regularly in the intensive care setting, and safety and effectiveness will be closely observed. The total participation duration includes this 28-day period or hospital stay, encompassing comprehensive clinical monitoring and data collection.

This survey investigates the safety of Ondexxya Intravenous Injection 200 mg in patients who received it to neutralize the anticoagulant effect of factor Xa inhibitors during life-threatening or unarrestable bleeding episodes. The study aims to understand the occurrence of safety events known as "safety specifications," including thrombotic events, infusion reactions, and re-bleeding, as well as to detect any unknown adverse drug reactions and evaluate factors affecting safety and effectiveness under real-world use conditions. The survey collects safety and effectiveness information from all patients treated with Ondexxya for these bleeding emergencies. It does not involve comparison groups or additional interventions but focuses on monitoring the outcomes and adverse reactions associated with the drug's use in everyday clinical practice. Participants' data will be observed to measure the incidence of adverse drug reactions and safety events within 30 days after treatment. The study gathers information on patient background factors that might influence safety outcomes. There is no specified follow-up treatment or additional procedures; the total observation period for outcomes is 30 days post-treatment.