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.
User-friendly technology
The latest generation of portable dialysis devices emphasize high-tech, user-friendly features. Tablo needs only a plug and tap water. NxStage can be combined with another device the company makes to use tap water as well.
Leslie Trigg, CEO of Outset Medical, said the Tablo device was designed to be patient-friendly in any setting, from an intensive care unit to a dialysis clinic, and if their application is approved by the FDA, eventually in the home setting. “The same machine that [the patient] becomes comfortable with in the hospital can follow the patient through their journey, whether that might be in a conventional clinic setting, or in the future all the way to home,” Trigg said.
Bruce Culleton, chief medical officer for CVS Kidney Care, said the company wanted to develop a device that would be easy to use for a broad population of patients, would ease the burden on patients and their caregivers, and help alleviate patients’ and caregivers’ fears about safety. Only half of patients trained to do home dialysis are still on the therapy one year later, Culleton noted.
“We do not believe that home hemodialysis will be sustainable if dropout rates are as high as they are today,” Culleton said. “That’s just not a way we think home hemodialysis is going to grow.”
As a patient, Tablo clinical trial participant Crawford said the flurry of new devices in development is encouraging. Often, he said, current dialysis options whether home or center-based are not “conducive to traveling,” which limits his professional prospects. He said he hopes the new technologies becoming available make travel easier.
“Technological advancements should help reduce the cost of these systems and give the patient more options,” he said.
Training and policy needs
In addition to the need for easier-to-use technology, systems-level and policy changes are needed to make home dialysis more widely available.
“While better technology can make it easier to facilitate the use of certain renal replacement therapies at home, healthcare system–level improvements can have a larger impact by ensuring implementation of comprehensive, effective approaches to the care of patients with end stage kidney disease,” said Leonid V. Pravoverov, MD, chief of nephrology at Kaiser Permanente’s East Bay service area.
Pravoverov was the lead author of a study published recently that showed Kaiser Permanente of Northern California was able to increase enrollment of new dialysis patients in home peritoneal dialysis (PD) from 15.2% in 2008 to 33.8% in 2018 with 80% continuing on home PD beyond one year. The results, which far outstripped the US-wide increase from 6.1% in 2008 to 9.7% in 2016, were enabled by a multi-disciplinary, systemwide initiative to expand PD. That program included identifying and educating patients with advanced chronic kidney disease about their options, providing continuing education and support for clinicians on how to provide PD, and a streamlined system process, noted the senior author of the work, Alan S. Go, MD, a research scientist in the Kaiser Permanente division of research.
“We firmly believe that there are additional opportunities to grow the population of kidney disease patients receiving home-based therapies, including peritoneal dialysis,” Go said. But he noted improvements in current regulations are needed, such as support for new models of care, including assisted-at-home dialysis, dialysis in skilled nursing facilities, and simplified rules for respite care.
A major hurdle to expanding home dialysis in the US is training physicians how to do it, said Golper, who runs a course called Home Dialysis University. But many physicians have not been trained, and Golper said he’d like to see parts of his course taught in every training program across the country.
“A big part of the problem is that doctors don’t know how to do home dialysis,” he said.
More telehealth is also needed to support patients doing home dialysis, agreed both Crawford and Golper. Crawford explained that it would be helpful to have easy audio and video conference access to a support team who could help home dialysis patients when issues arise.
Starting in January 2019, Medicare began covering telehealth visits for home dialysis patients, Golper noted.
“That in and of itself should have caused an explosion of home dialysis,” Golper said. But physicians, he noted, are still learning to use the technology. Additionally, there can be technical hurdles. For example, he and his colleagues will only start offering telehealth in January because changes had to be made to their electronic medical records system to enable it.
“There’s no question, no question that technology is going to play a role [in expanding access to home dialysis, whether it’s simpler to use equipment, or communication, or telehealth,” Golper said. “All those things will be positive, but none of it can happen until the physicians know how to do the therapy.”
Culleton said that “systems changes are more important than technology,” for example, implementing some of the changes outlined in the AAKH. It’s also important, he said, to address the overall costs of care to enable providers to improve the way they care for patients receiving dialysis at home.
“There are a lot of things that need to happen to change behavior at the provider and physician level,” he said.
