US-based healthcare company CVS Health has initiated a clinical trial to evaluate the safety and efficacy of the HemoCare Haemodialysis System for administration of home haemodialysis.
Home haemodialysis is set to facilitate longer, more frequent dialysis treatments compared to in-centre treatments and available clinical research indicates that longer, more frequent haemodialysis treatments result in better health outcomes in appropriate patient populations.
CVS said that it has designed the device incorporating safety features to make home haemodialysis simple for patients, and its clinical trial is planned to be conducted at ten sites in the US, enrolling 70 patients.
CVS Health executive vice president and chief transformation officer Alan Lotvin said: “We’re working now to change the kidney care paradigm by bringing to market programs and tools to improve early detection of kidney disease and provide comprehensive education and support to help delay the transition to dialysis.
“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 U.S. Food and Drug Administration as we evaluate this device.”
Usually, haemodialysis includes a machine cleaning a patient’s blood, most commonly in a dialysis centre three times per week.
The expanding scientific literature shows longer duration haemodialysis treatments, which are also challenging through in-centre dialysis, are set to improve the clinical outcomes for patients.
CVS said that investigators would measure the safety and performance of its HemoCare Haemodialysis System during the trial.
The initial phase of the trial conducted at medical facilities includes training the clinical study subjects and their caregivers on the system before switching to home-based dialysis.
Primary study endpoints of the trial include adverse events along with regular tests to measure the dose efficacy of dialysis delivered by the device.
CVS said that it has developed the HemoCare Hemodialysis System in collaboration with DEKA Research & Development, a US-based a technology company.
DEKA Research & Development founder Dean Kamen said: “DEKA designed this device with patients in mind to help make home dialysis safe and simple. CVS Health is uniquely positioned to redefine identification, education and treatment for chronic kidney disease, making them our ideal partner.”