Meerut

Researchers are evaluating the safety, effectiveness, behavior in the body, and biological effects of WAL0921 in adults with certain glomerular kidney diseases that cause proteinuria. These diseases include diabetic nephropathy, primary focal segmental glomerulosclerosis, treatment-resistant minimal change disease, primary immunoglobulin A nephropathy, and primary membranous nephropathy. This study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial designed to better understand how WAL0921 works and its safety profile in these patients. Participants will be randomly assigned to receive either WAL0921 or a placebo through an intravenous infusion every two weeks for a total of seven infusions. After the treatment period, all participants will be monitored for an additional 24 weeks to observe any long-term effects. The study setup allows comparison between the investigational drug and placebo to assess treatment impact. During the study, participants will be closely monitored for any treatment-related side effects from the start of the study through week 36. Regular assessments will include safety checks and evaluations to track how the drug affects their condition. This monitoring aims to ensure participant safety and to measure important outcomes related to kidney health and proteinuria over the entire study period.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.