West Springfield

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.

Researchers are evaluating the BDae WavelinQtrade; EndoAVF System in a prospective, single-arm, multi-center post-market surveillance study. The study focuses on patients with end-stage kidney disease who require dialysis and need an arteriovenous fistula (AVF) for treatment. This device is being studied for its ability to help create an AV fistula, which is critical for dialysis access. Participants will undergo creation of an endoAVF using the WavelinQ EndoAVF System. This treatment is delivered through a device designed to create the fistula in the blood vessels needed for dialysis. The study does not mention a comparison group, as it is a single-arm study, focusing on monitoring the outcomes after device use. During the study, participants will be followed for up to 6 months after the procedure to assess the success of fistula creation, how well the fistula remains open (patency), and any serious adverse events related to the device or procedure within 30 days. Follow-up includes clinical monitoring and imaging assessments to evaluate the fistula's function and safety of the device. Participants are expected to comply with study visits and follow-up assessments throughout the study period.