Most innovations medicine occur by asking one simple question. Is there a better way? Physicians at the Kidney Research Institute of the University of Washington have asked that question about hemodialysis treatments – lengthy procedures that filter a patient’s blood when the kidneys no longer function properly.
The institute is developing a wearable artificial kidney that could completely change the paradigm for some of these patients with impaired kidney function.
Earlier this week, at MD&M West, Jonathan Himmelfarb, MD, who servers as director of the Kidney Research Institute, spoke about the development of the artificial kidney and gave a timetable on when such a technology could be up for review by the FDA.
“There has been an increase in the number of people with kidney failure who were treated particularly with dialysis and particularly with hemodialysis,” Himmelfarb said. “Now there are about 600,000 people in the United States today in which the vast majority - close to 500,000 are treated dialysis centers.”
Typically, these patients go to dialysis three times a week with a four-hour treatment. These treatments have significant impact on lifestyle, but even more than that the mortality and morbidity of these patients is very high.
“The average person, even today, who starts dialysis will survive for about three to four years,” Himmelfarb said. “The mortality is about 20% per year. With what we provide for dialysis function today, we don’t really restore kidney health.”
In 2012, the FDA issued out a challenge to innovators to develop a technology to address kidney failure patients.
The Kidney Research Institute, submitted an application to the FDA, and was one of three chosen out of 32 applicants to move forward with the development of an artificial kidney. The institute conducted an initial trial in Seattle.
The wearable artificial kidney is a 10-pound, battery-powered device worn on a belt that provides around-the-clock, continuous dialysis.
“A lot of the components will work like dialysis does today,” Himmelfarb, told MD+DI. “You take blood out of the body and you circulate it across a membrane that allows certain toxins to move to the other size of the membrane. You drop them on the other side and the blood goes back into the patient. That’s the basic concept of hemodialysis, and that will be the same [for the device].”
An early trial of a prototype of the device showed that five out of seven patients completed the full 24 hours of treatment. Two others had to stop participation in the trial because of technical issues with the device. The treated patients were able to walk in the hospital's halls while the device continuously cleaned their blood.
Himmelfarb said the Institute’s goal is to take a more refined version of the wearable artificial kidney to take through clinical trials in 2022. He said a commercial vehicle to market such a device hasn’t been established yet.
“First, we have to generate all of the intellectual property and then we’ll eventually develop a commercialization strategy,” he said. “But right now we’re focused on the science of trying to make this work.”
There have been other projects aimed at providing alternative solutions to patients reliant on dialysis machines.
In 2016, Vanderbilt University researchers revealed their work on microchip filters that can help remove waste products and hopefully keep patients off dialysis. Each chip acts as a filter and can be inexpensively produced and precisely tailored to individual patient needs.
The device was designed to operate with approximately fifteen microchips and uses live kidney cells that will grow around the microchip filters to help imitate natural kidney functions.