Results from the first-in-humans trial of the automated wearable kidney (AWAK) found the device to be safe, according to work presented at Kidney Week 2019. And results from an animal study of a similar device, the Wearable Artificial KIDney (WEAKID) presented at the meeting set the stage for that device to progress to human trials as well.
The developments are the latest steps in progress toward the development of a wearable artificial kidney.
Developing an artificial kidney is now a priority of the US government under Advancing American Kidney Health, established by Executive Order in July 2019. The Kidney Health Initiative has provided the technical roadmap to achieve this goal, and KidneyX, a public-private partnership between the US Department of Health and Human Services (HHS) and ASN is holding a series of prize competitions to advance development of innovative solutions to improve the lives of those living with kidney diseases. To actualize this goal, a formal Request for Information (RFI) was released by KidneyX for an artificial kidney prize.
Nanotechnology and the use of sorbent technology that can regenerate dialysate have made it possible to create a wearable or implantable artificial kidney, according to a recent review in the American Journal of Kidney Diseases. Now, those early devices are being tested in animals and small human trials to pave the way for the larger human studies that would be needed to gain US Food and Drug Administration clearance for the devices. If these efforts are successful, they could reduce the burden of care on patients receiving in-center or home dialysis.
“With all of the current modalities, patients are hooked up for hours a day,” said Megha Salani, MD, assistant professor in the Department of Nephrology at Vanderbilt University Medical College and lead author of the review. “It really affects their ability to work and do things they enjoy. With wearables they would be able to keep on a more normal schedule.”
In the AWAK trial, 15 peritoneal dialysis patients in Singapore underwent 9 AWAK therapies over the course of 3 to 4 days. None of the patients experienced serious adverse events during therapy or at 1-week or 1-month follow-up visits after the trial, although 71% reported abdominal discomfort, 36% reported bloating, and 36% had fibrin in the drain. All the patients who completed at least one AWAK therapy achieved weekly peritoneal Kt/Vurea ≥1.7 with median weekly peritoneal Kt/Vurea = 3.04.
“The 15-patient first-in-human trial has shown that the device is safe to use for up to 9 therapies each running up to 7 hours each," said lead author Marjorie Wai Yin Foo, MD, head and senior consultant in the Department of Nephrology at Singapore General Hospital in China, who presented the results from the AWAK trial.
Vanderbilt’s Salani called the results “very promising,” although she cautioned that it is difficult to draw conclusions from the short duration of the follow-up.
“At the very least we can feel satisfied the labs are better and certainly not inferior,” she said.
Results of a small study in uremic pigs of 8 hours of daytime, 3 animals’, or nighttime, 8 animals’, use of WEAKID, another wearable kidney that uses sorbent technology to regenerate dialysate, were also presented at the meeting.
Senior author Giulia Ligabue, PhD, of the Laboratorio di Nefrologia Policlinico at the University of Modena, Italy, said the results compare well to conventional peritoneal dialysis. “WEAKID treatment was well tolerated and no serious adverse events occurred,” Ligabue said. “Treatment improves the mass transfer area coefficient (MTAC) and plasma clearance. In the pig model, the system enhances clearance of creatinine [2-fold] and of phosphate [1.6-fold], significantly increases the MTAC [1.9-fold], and it doesn’t show acute systemic toxicity.” The group hopes to next test the device in clinical trials.
“This innovative treatment may offer improved blood purification, prolonged technique survival and optimal patient tolerability compared to conventional peritoneal dialysis,” Ligabue said. “WEAKID will represent a huge leap forward for dialysis patients and it is expected to significantly improve health and quality of life."
Salani said having multiple devices in development may drive competition and lead to improved quality in artificial kidney devices. It may also help increase funders' interest in this area.
“It’s a great thing for the field of nephrology,” she said. She cautioned that there may still be hurdles ahead, such as unanticipated complications associated with the use of the devices.
Foo said the next step for her team will be conducting a multi-center, international trial to demonstrate the safety and efficacy of the AWAK over a longer time frame.
“If future studies prove to be successful, this technology will revolutionize the way peritoneal dialysis has been done for the past decades,” Foo said. “Patients on peritoneal dialysis will have greater freedom in terms of traveling, flexibility of therapy, and ease of doing the procedure.”
“Effect of Automated Wearable Artificial Kidney (AWAK) Device on Toxin Clearance and Safety in Peritoneal Dialysis Patients” Oral Abstract 101
“Evaluation of a Wearable Artificial Kidney for Peritoneal Dialysis in a Uremic Pig Model” Poster 522