Trial results positive for AWAK-PD device in Japan
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An 11-year development cycle with an artificial kidney device using an approach similar to PD therapy has been successful in Japan, according to a speaker here.
AWAK Technologies, based in Singapore, received an FDA breakthrough device designation in January for its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable PD system that incorporates AWAK’s sorbent technology. The company received the designation after its human safety trial, completed in October 2018 at the Singapore General Hospital, showed the AWAK PD was able to efficiently remove the accumulation of toxins from the body and patients in the trial did not experience any serious adverse events.
In the trial, patients underwent three therapies a day during a 3-day period at the hospital. Time on therapy ranged from 3.5 to 6 hours per treatment, Marjorie Foo Wai Yin, MD, head of renal medicine and director of Singapore General Hospital’s Peritoneal Dialysis Program, who reviewed the results of the trial, said.
“In normal dialysis, you would infuse a large amount of dialysate, and then drain the fluid during the treatment,” Foo Wai Lin said. “So for 10 hours of therapy, you would have 10 liters of dialysate. In AWAK therapy, we regenerate the dialysate at 2 liters an hour. For the patient, we can have continuous high clearance, high adequacy and lower the burden in terms of storage needs for PD fluid.”
Foo Wai Yin said the researchers experimented with different dialysis flow rates during the continuous therapy and settled on 2 liters an hour.
Results of the trial, Foo Wai Yin said, focused on clearance and urea reduction. There were concerns about a rise in serum sodium during therapy, but it was not seen during the trial, she said. “Patients consistently achieved a targeted Kt/V of 1.7,” she said. – by Mark E. Neumann
- Reference:
- Foo Wai Yin, M. Dialyzing to LIVE, not living to dialyze: 11 years journey with AWAK’s vision.
Disclosure: Foo Wai Yin reports no relevant financial disclosures.