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Abstract: FR-OR101

Effect of Automated Wearable Artificial Kidney (AWAK) Device on Toxin Clearance and Safety in Peritoneal Dialysis Patients

Session Information

Category: Dialysis

  • 703 Dialysis: Peritoneal Dialysis

Authors

  • Foo, Marjorie Wai Yin, Singapore General Hospital, Singapore, Singapore
  • Htay, Htay, Singapore General Hospital, Singapore, Singapore
  • Gow, Sheena, AWAK Technologies Pte Ltd, Singapore, Singapore
  • Gori, Mandar, AWAK Technologies Pte Ltd, Singapore, Singapore
  • Jayaballa, Mathini, Singapore General Hospital, Singapore, Singapore
  • Huda, Siti Noor, AWAK Technologies Pte Ltd, Singapore, Singapore
  • Lim, Jason Tze chern, AWAK Technologies Pte Ltd, Singapore, Singapore
  • Oei, Elizabeth Ley, Singapore General Hospital, Singapore, Singapore
  • Venkataraya, Suresha Belur, AWAK Technologies Pte Ltd, Singapore, Singapore
  • Wu, Sin yan, Singapore General Hospital, Singapore, Singapore
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.

Serum Solute Concentration
SolutesPre-AWAK PDPost-AWAK PDp-value^
Median (Range Min, Max)
Urea*20.8 (18.2-21.8)14.9 (13.1-15.4)0.001
Creatinine#976 (727-1058)668 (540-827)0.001
Phosphate*1.7 (1.5-1.8)1.5 (1.3-1.7)0.03
B2-microglobulin*29114 (23753-36540)26339 (26339-34192)0.048

^pre-post therapy serum solutes level (Wilcoxon signed-ranks test); *: mmol/L; #: µmol/L

Funding

  • Commercial Support