Abstract: TH-OR69
Prepivotal Study Exploring Safety, Efficacy, and Usability of the Automated Wearable Artificial Kidney (AWAK) PD Device
Session Information
- Home Dialysis Hodgepodge: Novel Mechanisms, Solutions, Technologies, and Ideas
October 24, 2024 | Location: Room 8, Convention Center
Abstract Time: 05:20 PM - 05:30 PM
Category: Dialysis
- 802 Dialysis: Home Dialysis and Peritoneal Dialysis
Authors
- Foo, Marjorie Wai Yin, Singapore General Hospital, Singapore, Singapore
- Brown, Edwina A., Imperial College London, London, United Kingdom
- Jain, Arsh, London Health Sciences Centre, London, Ontario, Canada
- Schreiber, Martin J., AWAK Technologies Pte Ltd, Singapore, Singapore
- Gow, Sheena, AWAK Technologies Pte Ltd, Singapore, Singapore
- Lim, Jason Tze Chern, AWAK Technologies Pte Ltd, Singapore, Singapore
- Singh, Sanjay, AWAK Technologies Pte Ltd, Singapore, Singapore
- Gori, Mandar, AWAK Technologies Pte Ltd, Singapore, Singapore
- Venkataraya, Suresha Belur, AWAK Technologies Pte Ltd, Singapore, Singapore
- Htay, Htay, Singapore General Hospital, Singapore, Singapore
Background
The AWAK PD is an innovative, wearable sorbent-based device providing tidal PD. The device, weighing about 3kg, automates fills and drains, with adjustable glucose for customized ultrafiltration (UF) requirements.
Methods
14 subjects underwent screening (30 days), titration period (up to 21 days), washout (2 days), and a treatment period of at-home use (7 days) with an optional extension (23 days), at a single Singapore hospital. A nomogram and PD prescribing titration guide were developed to determine cartridge type, therapy duration, initial fill tonicity and glucose (absorbed/added) to achieve target UF. The primary aim was to complete at least 70% of sorbent dialysis in each therapy. Other aims included maintaining body weight within 5% of target weight, having stable plasma biochemistry and electrolytes, and assessing patients’ experience using symptom and device usability questionnaires. Illness Intrusiveness Rating Scale (IIRS) was assessed in the 3 subjects using AWAK for 30 days.
Results
11 subjects (10 male, mean±SD age 60±7 years and dialysis vintage 21±9 months) entered the 7-day treatment period, with 1 withdrawal. 3 of these subjects completed 30 days. No device-related serious adverse events occurred. 95% of therapies conducted (76/80) were completed. Optimal UF was achieved by adjusting the dextrose concentrations. All subjects remained within 5% of their target weight. Table 1 depicts plasma biochemistry and UF results. Usability scores were high; 10/11 patients agreed they were confident using the device and 8 felt the device was useful, 3 were neutral. IIRS scores improved in the 3 patients on AWAK for 30 days (average score: 38 at baseline; 20 after AWAK).
Conclusion
AWAK PD is safe to use and a reduction in the IIRS is noted after 30 days of use; reasons could range from ease of use of the device to increased flexibility to suit their lifestyle. Minor device modifications can be done to optimize solute clearance.
Table 1: Summary of analytes and UF - median (IQR). Interim data - database lock in Aug
| Measure | UF (mL) | Weight (kg) | Urea (mmol/L) | Creatinine (μmol/L) | β2-microglobulin (µg/L) | Sodium (mmol/L) | Potassium (mmol/L) | Bicarbonate (mmol/L) |
| Baseline | 340 (158-669) | 73.7 (64.9 - 88.0) | 20.8 (19.9 - 22.9) | 866 (761 - 1008) | 23787 (20397 - 29819) | 138 (136 - 141) | 4.2 (3.8 - 4.5) | 26.0 (25.0 - 28.1) |
| AWAK | 599 (288-829) | 73.8 (63.9 - 87.0) | 24.3 (21.2 - 28.0)* | 987 (835 - 1066)* | 23707 (20816 - 33471) | 138 (136 - 139) | 4.3 (4.1 - 4.5) | 24.6 (23.8 - 26.2) |
*p-value <0.05
Funding
- Commercial Support – AWAK Technologies Pte Ltd