As a veteran of both in-center and home dialysis, patient Richard Crawford knows that dialysis is a “tough proposition” in terms of time and its impacts on the body. But he was impressed by a new experimental home dialysis device called Tablo that he tried as part of a clinical trial.
“It seemed to sync with my body much better than both in-center devices and systems I used at home,” Crawford said. He explained he found it intuitive to use, that it reduced the likelihood of user error, and gave him better biochemical clearance. In fact, he said he had enough energy after using the device to jump on the treadmill within a couple hours of finishing.
Results of the trial, which the device’s manufacturer Outset Medical (San Jose, CA) is using to apply for US Food and Drug Administration (FDA) clearance to market the device for home dialysis, were presented at Kidney Week 2019 in Washington, DC. The trial enrolled 30 patients from 8 US dialysis units and met its endpoints for safety and efficacy, and 28 patients completed the treatments. Patients received home dialysis 4 times per week for 32 treatments after first completing 32 in-center treatments and 8–16 transition treatments, according to the abstract. The device has already received FDA clearance for use in-center.
“Above and beyond anything, this device has shown that it works at home,” said Principle Investigator Troy Plumb, MD, associate professor of medicine at the University of Nebraska Medical Center. With FDA clearance for home use, “it’s going to give patients another option,” he said.
The Tablo device is one of a growing number of high-tech, user-centric home dialysis devices in development. A clinical trial for another experimental home dialysis device from CVS Health called the HemoCare Hemodialysis System launched in July 2019. The company hopes to win FDA approval for the trial and be able to market the device by 2021. A British company called Quanta also launched a US study of its SC+ home hemodialysis system in August 2019 as a step toward seeking FDA clearance.
Fresenius’ NxStage System One device, which allows patients to administer home hemodialysis without help, received FDA clearance in 2017 and has greatly expanded access to home dialysis, according to Thomas Golper, MD, Medical Director of Home Dialysis at Vanderbilt University Medical Center. NxStage currently accounts for much of the market for home dialysis in the US.
“NxStage is easier to use than the equipment we were using before, and the more frequent [dialysis sessions with the device] have reduced the complication rate,” said Golper, who also serves on the advisory board for NxStage. He explained the device also doesn’t require changes to patients’ homes to use and patients can be trained to use it in a shorter time frame.
These developments, along with Advancing American Kidney Health (AAKH), created by an executive order by President Donald Trump in July 2019, are expected to help increase the number of patients on home dialysis. The AAKH will create payment incentives to increase patient access to home dialysis and kidney transplant.