Baxter International Inc. announced that the first patients have been enrolled in a U.S. clinical trial for the company’s on-demand peritoneal dialysis (PD) solution generation system. The innovative system is designed to improve the patient experience by making PD solutions in small batches in the patient’s home. The Food and Drug Administration (FDA) has indicated that the company may proceed with the prospective, multi-center clinical trial. The system brings together Baxter’s pioneering innovations in home dialysis, drug delivery technology and expertise in water filtration systems. The on-demand technology uses a small water filtration device, concentrates and Baxter’s Amia automated peritoneal dialysis system to turn patient’s tap water into dialysis solution, as it is needed to complete each therapy session. The innovative system is designed to be more flexible to meet individual patient needs, while simplifying how clinicians manage therapy for their patients. PD solutions are available in different concentrations of glucose, with higher concentrations removing more fluid and waste than lower concentrations. Making solutions on demand means that a physician could add or change the concentrations being used in therapy in near real-time, through Baxter’s Sharesource remote patient management system. The flexibility to adapt therapy would be a significant improvement from current practice, where a clinician manually creates a new prescription, places an order for pre-made solutions and waits for delivery, or keeps even more boxes of solutions on-hand in patients’ homes. The clinical trial assesses the efficacy and safety of the system, with each participant using the new system for 12 weeks. Following conclusion of the trial and study reporting process, Baxter expects to submit a New Drug Application (NDA) for the concentrates and 510(k) for the device to the FDA.