Baxter Starts U.S. Clinical Trial for on-Demand Peritoneal Dialysis Solution System

Baxter International Inc., a global innovator in renal care, 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 system is designed to improve the patient experience by making PD solutions in small batches in the patient’s home. The U.S. Food and Drug Administration (FDA) has indicated that the company may proceed with the prospective, multi-center clinical trial.
 
“We are on a journey to transform how kidney disease is identified, managed and treated, with a focus on improving outcomes for patients,” said Laura Angelini, general manager of Baxter’s Renal Care business. “Our on-demand technology is the cornerstone of our innovation pipeline, as we believe the technology will open up new possibilities for therapy delivery while improving the experience for patients today.”
 
The system brings together Baxter’s 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.
 
Today, patients receive up to 40 boxes of pre-made dialysis solution every four weeks, weighing in at more than 900 pounds on average. These boxes take up a lot of space in a patient’s home, often filling a closet or spare bedroom. Making solution on demand allows Baxter to improve the PD experience by eliminating heavy, six-liter bags that patients must carry around their homes while setting up therapy. On-demand solutions may also drastically reduce the storage space patients need. Because the concentrate bags are smaller and can be used for several dialysis sessions, patients may also be able to reduce the amount of plastic and cardboard they recycle and dispose of daily.
 
The 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.
 
Baxter’s on-demand solution technology is an investigative product and not approved for use.
 
Patients with end-stage renal disease need dialysis to replace their lost kidney function. PD therapy is done by the patient at home, offering flexibility to choose when therapy is done. Many patients choose PD to have more time for family and work commitments. The therapy works inside the body, using the abdominal lining (peritoneal membrane) as a natural filter to remove toxins from the bloodstream. PD solution dwells in the cavity with toxins being pulled into the solution before draining. The process then repeats itself three to four times during each therapy session.
 
Every day, millions of patients and caregivers rely on Baxter’s portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, the company has been operating at the intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations.