Baxter’s New Trial for High-Dose Dialysis

Baxter International Inc. announced in mid-March 2016 it had enrolled the first patient in a US clinical trial for VIVIA, an investigational home hemodialysis (HD) system being developed by Baxter (Deerfield, IL), and DEKA Research & Development (Manchester, NH).

The trial is designed to study more frequent, extended-duration nighttime home HD therapy (high dose HD), which will be performed in dialysis facilities as well as in homes. The study will assess product safety and adequacy of dialysis.

High dose HD therapy is a more frequent therapy usually performed as short daily treatments at least 5 days per week for sessions that typically run less than 4 hours, or as nocturnal treatments wherein sessions are conducted for more than 6 hours while a patient sleeps. High dose HD therapy is associated with improvements in survival and clinically important health measures, including health-related quality of life, compared with conventional hemodialysis, Baxter noted in its announcement.

The VIVIA investigational home hemodialysis system includes an integrated water purification module, safety sensors and one-button fluid infusion. Its use is limited by federal law to investigational use only in the US.

Market Realist, an investment information technology company, reported that Baxter’s US peritoneal dialysis business exhibited the highest quarterly growth in the fourth quarter of 2015.