Udupi

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating the optimal duration of levetiracetam treatment in patients with primary brain tumors who have experienced seizures. This phase 3 randomized controlled trial aims to compare a shorter course of levetiracetam with the current standard longer course. The goal is to determine whether stopping levetiracetam earlier will not lead to an increased risk of seizure episodes, while considering the side effects such as headache, drowsiness, muscle coordination loss, and psychological challenges commonly associated with this medication. Participants will be randomized into two groups the standard arm, where patients continue levetiracetam at the same dose typically 1000-3000 mg per day in divided doses for two years, and the experimental arm, where the drug is gradually reduced by 250-500 mg each week and then stopped. Follow-up visits will occur every 3 to 6 months, with routine neuroimaging done every 6 to 12 months according to tumor type. Quality of life assessments will be performed every six months. If seizures recur, levetiracetam or additional antiepileptic medications will be administered as needed per usual care. During the study, patients will continue standard treatments for their brain tumors, including any necessary adjuvant therapies. Researchers will monitor seizure-free survival over two years from randomization as the primary outcome. Secondary outcomes include overall survival, progression-free survival, cost-benefit analysis, and quality of life measures over seven years. The study includes safety monitoring through planned interim analyses and will enroll 604 patients over seven years at two centers.

Chronic kidney disease CKD is a major cause of death worldwide, with a rising impact in South Asia. In this region, one in seven adults has CKD, and IgA nephropathy IgAN is the most common primary glomerular disease affecting adults. Studies show South Asians with IgAN experience severe and rapid kidney function decline. Recent trials indicate that steroids benefits may fade over time, highlighting the need for longer-term treatment options. This trial aims to evaluate commonly available generic drugs alongside standard care to improve kidney outcomes in South Asian adults with biopsy-proven IgAN at high risk of progression. The trial is a multi-center, randomized, single-blind, multi-arm, and multi-stage platform study comparing several drugs added to standard care SoC against SoC alone. SoC includes maximal tolerated doses of ACE inhibitors or angiotensin receptor blockers and a steady dose of SGLT2 inhibitors. The drugs studied include low-dose oral prednisolone, gut-directed budesonide, mycophenolate mofetil, hydroxychloroquine, and a non-steroidal mineralocorticoid receptor antagonist, with dosing schedules ranging from two months to 24 months. The trial allows adaptive changes, including adding new treatment arms based on interim analyses. Participants will be adults aged 18 to 65 with biopsy-proven primary IgAN and specific kidney function and proteinuria criteria despite standard treatment. They will undergo regular assessments over 24 months, including kidney function tests eGFR, proteinuria measurements, medication adherence, and patient-reported outcomes. The primary outcome is the change in the annualized eGFR slope over two years. Secondary outcomes include changes in proteinuria, disease progression markers, adverse events, and quality of life measures. Safety and treatment effects will be closely monitored throughout the study period.