Drugstores chain CVS Health has launched a clinical trial to assess at-home haemodialysis device HemoCare, which has been designed by DEKA Research & Development.
The study aims to assess the safety and efficacy of using the HemoCare Hemodialysis System at home with a clinical trial of approximately 70 patients across up to ten sites in the US.
Home haemodialysis is expected to allow longer, more frequent dialysis and potentially better health outcomes compared to in-centre treatments in patients with end stage renal disease (ESRD).
CVS Health executive vice-president and chief transformation officer Alan Lotvin said: “For those patients who do progress to dialysis, we are working to bring a new solution to the consumer that addresses the current barriers to and limitations of existing dialysis options, and we are working closely with the US Food and Drug Administration (FDA) as we evaluate this device.”
The initial phase of the haemodialysis trial will involve training participants and their caregivers on the system at medical facilities. The study will then transition to home dialysis.
Primary endpoints of the trial are adverse events and tests to measure the dose efficacy of dialysis delivered by the HemoCare system.
Health unit CVS Kidney Care is responsible for the HemoCare evaluation and other early kidney disease identification and stratification programmes. It is working on multiple solutions to improve health outcomes for patients suffering from chronic kidney disease (CKD) and ESRD.
In the US, more than 37 million people are living with kidney disease, including around 700,000 with ESRD, noted the company.
Out of the total ESRD patients, more than 500,000 are on active dialysis and more than 120,000 new individuals are diagnosed with the disease annually.
Medicare currently spends $35bn a year on dialysis care.