West Springfield

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.

Researchers are evaluating the BD WavelinQ EndoAVF System for creating arteriovenous fistulas AV fistulas in adults who need dialysis due to end-stage kidney disease. This prospective, single-group, multi-center post-market surveillance study aims to observe how well this device works and how safe it is when used in real-world patients who require dialysis access. Participants will have an AV fistula created using the WavelinQ EndoAVF System, which is a device designed to help form the connection between an artery and a vein needed for dialysis. The study focuses on patients already on dialysis or those expected to need dialysis within six months and involves follow-up assessments up to 24 months after the procedure to evaluate the fistulas function and any related serious events. During the study, participants will be regularly monitored through ultrasound and other imaging methods to measure fistula maturation and function at multiple time points from 2 weeks up to 24 months after the procedure. Researchers will track success rates of cannulation, patency of the fistula, any additional procedures needed, and safety outcomes. The total participation duration can extend up to two years to gather comprehensive data on the devices performance and patient outcomes.