Bloomfield

This research aims to evaluate the safety, tolerability, and impact on albuminuria of the drug MZE829 in adults who have proteinuric chronic kidney disease and carry the APOL1 high-risk genotype. This Phase 2 open-label study focuses on participants with specific genetic markers associated with kidney disease to better understand treatment effects. Participants will receive MZE829 in the form of oral capsules. The study involves monitoring the participants over a 12-week period to assess the drug's safety and how well patients tolerate it. Researchers will also measure changes in albuminuria, which reflects kidney function. During the study, participants will be closely monitored for any adverse events from the first day through week 12. Safety assessments and laboratory tests will be performed to track the drug’s effects. The main goal is to determine how safe and tolerable MZE829 is, along with its impact on kidney disease markers over the treatment duration.

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.

Researchers are evaluating VX-147 for its effectiveness, safety, tolerability, and how the body processes it in adults and children aged 10 to 65 who have apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. This study is a Phase 2/3 trial designed to better understand treatment options for this specific kidney condition. Participants will receive either VX-147 or a placebo, both given as oral tablets. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment period. The trial consists of two parts: Part A focuses on treatment effects over at least 48 weeks, while Part B involves continued safety and tolerability observation for approximately four years after the last participant enrolls. Throughout the study, participants will undergo regular assessments including measurements of urine protein to creatinine ratio and kidney function via estimated glomerular filtration rate (eGFR). Safety is monitored by tracking adverse events and serious adverse events. Data will be collected during the treatment period and followed long-term to evaluate both efficacy and safety outcomes, with some measures assessed at interim and final analyses over at least two years.