Torres Novas

Alport syndrome (AS) is a rare genetic disorder caused by changes in specific genes that produce collagen, leading to kidney disease, hearing loss, and eye abnormalities. People with AS are at high risk of developing chronic kidney disease, where the kidneys gradually lose their function, often marked by excess protein in the urine called proteinuria. This study focuses on evaluating BAY 3401016, a monoclonal antibody designed to block the protein Semaphorin 3A, which may contribute to kidney damage in AS, aiming to slow kidney function loss in adults with rapidly progressing AS. Participants will receive either BAY 3401016 or a placebo in a randomized, double-blind, parallel group Phase 2a study. The study includes an extension phase to further assess the treatment's effects. The treatment duration covers at least 24 weeks with follow-up visits extending up to 90 days after the end of treatment. The study measures the urinary albumin creatinine ratio (UACR) over weeks 16, 20, and 24 to evaluate kidney function. During the study, participants will undergo regular assessments including kidney function tests and urine measurements to monitor protein levels. Safety and efficacy will be tracked throughout treatment and follow-up. The study includes adults aged 18 to 45 with specific criteria related to kidney function and proteinuria levels. Overall participation spans the treatment period plus a 90-day post-treatment follow-up, with researchers closely observing changes in kidney health and safety outcomes.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.