Meerut

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents who have a kidney condition known as focal segmental glomerulosclerosis FSGS. This Phase 3 clinical trial aims to determine whether BI 764198 helps improve kidney function in people with primary FSGS or genetic FSGS linked to TRPC6 gene variants. The study is randomized and placebo-controlled, meaning participants are randomly assigned to receive either the medicine or a placebo, and neither the participants nor the researchers know which treatment each person receives. Participants take either BI 764198 tablets or placebo tablets once a day for up to two years, while continuing their usual medication for FSGS. The study involves two groups running in parallel. The main treatment period lasts 104 weeks about two years, during which the participants regularly visit the study site approximately every three months. Both groups are compared to see if BI 764198 affects kidney protein levels and function. During the study, participants provide urine samples regularly to assess their kidney health. Researchers measure changes in urine protein-creatinine ratio and kidney filtration rate from the start to the end of the treatment period. Questionnaires about health-related quality of life are also completed. Doctors monitor participants health and note any side effects throughout the two years. This thorough follow-up helps understand how BI 764198 impacts kidney disease and overall well-being.

Researchers are studying the safety, effectiveness, and how the body processes the investigational drug WAL0921 in adults with various glomerular kidney diseases and proteinuria. These include diabetic nephropathy and rare conditions such as primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to evaluate WAL0921 compared to a placebo. Participants will be randomly assigned to receive either the investigational drug WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. The study includes a treatment period followed by a 24-week follow-up after the last infusion to monitor participants. The treatments are given in parallel groups to compare their effects and safety. During the study, participants will undergo regular assessments including monitoring for adverse events from the start through Week 36. Researchers will also measure changes in albuminuria, proteinuria, and kidney function markers such as estimated glomerular filtration rate over 24 weeks. These evaluations help determine how the drug affects kidney disease markers and overall safety. The total participation time includes treatment and follow-up periods lasting several months.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.