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Title In-vitro to In-human – The Successful Journey of Automated Wearable Artificial Kidney (AWAK) in Peritoneal Dialysis. |
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Type Oral Presentation |
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Theme 18th Asian Colloquium in Nephrology (18th ACN 2019) |
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Topic Dialysis: Peritoneal Dialysis |
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Main Author Marjorie Foo1 |
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Presenting Author Marjorie Foo1 |
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Co-Author Siti Noor Huda Jamaluddin2 Mandar Gori2 Sheena Gow2 Htay Htay1 Mathini Jayaballa1 Jason Lim2 Elizabeth Ley Oei 1 Suresh Venkataraya2 Sin Yan Wu1 |
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Department / Institution / Country Department of Renal Medicine / Singapore General Hospital / Singapore1 AWAK Technologies Pte Ltd / AWAK Technologies Pte Ltd / Singapore2 |
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Abstract Content: Introduction, Method, Result, Conclusion Objective: To report key developmental milestones of AWAK (Automated Wearable Artificial Kidney), a sorbent-based wearable and ultraportable peritoneal dialysis (PD) device. Method: In-vitro proof of concept (PoC) study assessed quality of regenerated dialysate by AWAK, followed by two tidal PD (TPD) studies, each on eight PD patients using automated PD machine. The first optimization TPD study used 4L/hour dialysate flow rate (DFR) with eight tidal/reserve volumes (Tv/Rv) ≤ 1.5L combinations, while second TPD study investigated four DFR using 0.25L/0.5L Tv/Rv combination. Further, AWAK’s safety was evaluated in-vivo in six nephrectomized pigs receiving AWAK therapies daily for one week. Next, an open, single-arm ‘First-in-Human’ (FiH) study examined AWAK’s safety in 15 PD subjects on daily continuous therapies for three days. Results: PoC study listed AWAK’s potential advantages, development challenges and their solutions. The first TPD study concluded that solute clearance and adequate ultrafiltration (UF) in high average transporter PD patients could be achieved with 0.25L/0.5L Tv/Rv combination at DFR of 4L/hr, without changing dialysate tonicity. The second TPD study demonstrated adequate solute and UF clearance were achieved at 1L/hour DFR with 0.25L/0.5L Tv/Rv combination. AWAK’s commercial design delivering at 2L/hour is based on successful TPD studies. Serious adverse events were not reported during in-vivo (four animals were successfully maintained on AWAK for one week) or FiH study (15 subjects underwent total 100 AWAK PD therapies). Subjects receiving at least one valid therapy (>3.5 hours) achieved weekly Kt/Vurea≥1.7. Significant reductions in serum urea, creatinine, β2 microglobulin and phosphate achieved by AWAK returned to pre-study levels during follow-up. Conclusion: AWAK, a novel wearable and ultraportable PD device, demonstrated efficacy and safety along all key in-vitro to in-human developmental milestones. Adequate solute clearance with reduction in device size and weight were achieved by combining small tidal volume with low DFR (<2L/hour). |