Udupi

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are evaluating the optimal duration of levetiracetam treatment in patients with brain tumors who have a history of seizures controlled by this medication. Levetiracetam is a commonly used anti-seizure drug in brain tumor patients, but it can cause side effects such as headaches, drowsiness, loss of muscle coordination, and psychological challenges. The study aims to determine if a shorter course of levetiracetam is as effective as the standard longer treatment in preventing seizures. This is a phase 3 randomized controlled trial comparing short-term and long-term levetiracetam use in this population. Participants will be adults over 18 years old with a primary brain tumor in the supratentorial area, who have had controlled seizures on levetiracetam alone for at least six months. They will be randomly assigned to one of two groups: the standard arm, continuing levetiracetam at doses typically between 1000-3000 mg per day for two years; or the experimental arm, where levetiracetam will be gradually reduced by 250-500 mg weekly until stopped. Both groups will continue to receive standard brain tumor treatments as per usual care. Follow-up visits will occur every 3-6 months, including neuroimaging every 6-12 months and quality-of-life assessments every six months. Participants will be monitored for seizure recurrence, with the primary outcome being seizure-free survival over two years from randomization. If seizures occur after stopping levetiracetam, the medication will be restarted. Additional antiepileptic drugs may be added if seizures happen while on levetiracetam. Safety and disease progression will be managed according to standard clinical practice. The study plans to enroll 604 patients over seven years, with an interim analysis to assess safety and effectiveness. This comprehensive monitoring includes regular clinical evaluations, imaging, and quality-of-life assessments.

Chronic kidney disease (CKD) is a major global health concern, ranking as the 12th leading cause of death with a rising prevalence, especially in South Asia where one in seven adults is affected. Among kidney diseases, IgA nephropathy (IgAN) is the most common primary glomerular disease in adults and leads to severe kidney damage over time. South Asian patients with IgAN tend to experience faster disease progression and worse outcomes compared to other populations. This trial aims to evaluate whether adding commonly available generic drugs to standard care can improve kidney function decline in adults with biopsy-confirmed primary IgAN in South Asia. Participants will be randomly assigned to receive one of several treatments alongside standard care, which includes the maximum tolerated dose of ACE inhibitors or angiotensin receptor blockers and a steady dose of a sodium-glucose cotransporter-2 inhibitor. The treatments studied include oral prednisolone, gut-directed budesonide, mycophenolate mofetil, hydroxychloroquine, and a non-steroidal mineralocorticoid receptor antagonist. Each medication is given according to specific dosing schedules ranging from months to two years. This multi-arm, adaptive trial allows for ongoing adjustments and comparisons of these treatments against the standard care alone. During the study, participants will be monitored regularly over two years with assessments including kidney function tests to measure the rate of change in estimated glomerular filtration rate (eGFR). Visits occur at baseline and every 3 months up to 24 months to track kidney health and treatment effects. Safety and kidney outcomes are carefully evaluated to understand the impact of these therapies on disease progression. The trial aims to provide evidence on effective treatment options to improve long-term kidney outcomes in this high-risk population.