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AWAK device effective for toxin removal in kidney failure — first in-human study

Peritoneal dialysis performed with an automated wearable artificial kidney (AWAK) can effectively remove toxins from the blood of patients with kidney failure. The findings come from a study presented at ASN Kidney Week 2019 at the Walter E Washington Convention Centre in Washington, DC.

Researchers are testing the potential of an Automated Wearable Artificial Kidney (AWAK) device for peritoneal dialysis (PD) treatments, which would allow dialysis to be performed on-the-go, overcoming the challenge of long hours of therapy and connection to large dialysis machines. A sorbent-based regenerative technology in the AWAK PD therapy allows for high dose dialysis to be delivered with a low volume of dialysis solution. The technology regenerates and reconstitutes used dialysis fluid into fresh fluid while removing toxins.

In a first-in-human study, 15 participants underwent over 100 AWAK PD sessions. There were no serious adverse events up to 1 month after treatment, and the AWAK PD sessions were effective at removing waste substances from the blood.

"The regenerative sorbent technology used in AWAK PD is an innovation with the potential to revolutionise the way peritoneal dialysis has been done in the past 40 years, providing portability and flexibility of treatment," said principal investigator Dr Marjorie Foo Wai Yin, (Singapore General Hospital). "This technology also helps to reduce wastes and save resources by reusing dialysis fluids."

Background: Patients undergoing dialysis face mobility and logistic challenges due to limited progress in dialysis technological advancement. Dialysate regeneration through use of sorbent technology led to the development of Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) device.
Methods: The first-in-human (FIH) study was conducted in Singapore between March 2016 and October 2018. The study aimed to evaluate safety of AWAK PD in 15 prevalent peritoneal dialysis (PD) patients who underwent up to 9 AWAK PD therapies over 3-4 consecutive days. Incidence of adverse event was monitored and serum and dialysate samples were collected. Study also aimed to examine weekly peritoneal urea. Patients were followed up weekly up to a month.

Results: Of 15 patients with median age 65.5 [Range Min, Max: 35, 73] years, male (67%), Chinese (80%), presence of coronary artery disease (27%), anuria (33%), with a median PD duration of 21 [4-147] months, none experienced any serious adverse events during or post AWAK PD therapy. The reported adverse events included abdominal discomfort (71%), presence of fibrin in the drain (36%) and bloating (36%). There was no significant difference in pre and post therapy weight. All patients who completed at least 1 valid therapy (n=14) achieved weekly peritoneal Kt/Vurea ≥1.7 with median weekly peritoneal Kt/Vurea =3.04 [IQR: 2.19-4.75]. Significant reduction in solute concentrations was observed with AWAK PD therapy (Table 1). Stable serum sodium (136[134-139] mmol/L), potassium (4.0[3.6-4.4] mmol/L), and bicarbonate (24.2[23.1-25.5] mmol/L) levels were reported during the study.
Conclusion: This FIH study showed that AWAK PD device was shown to be safe on 15 PD patients with appropriate solute clearance and no observed water retention.

Foo, Marjorie Wai Yin, Htay, Htay, Gow, Sheena, Gori, Mandar, Jayaballa, Mathini, Huda, Siti Noor, Lim, Jason Tze chern, Oei, Elizabeth Ley, Venkataraya, Suresha Belur, Wu, Sin yan

[link url="https://www.sciencedaily.com/releases/2019/11/191108171643.htm"]American Society of Nephrology material[/link]

[link url="https://www.asn-online.org/education/kidneyweek/2019/program-abstract.aspx?controlId=3234367"]ASN Kidney Week 2019 abstract[/link]

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