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Proof of Concept Study of Point-of-Care Dialysate Generation by Viva Komfort Automated Peritoneal Dialysis System in a Porcine Model

Authors

Arsh Jain, London Health Sciences Centre, London, Ontario, Canada
Prashanth Kumar, Desert Cities Dialysis, Victorville, California, United States
Marjorie Wai Yin Foo, Singapore General Hospital, Singapore, Singapore
Htay Htay, Singapore General Hospital, Singapore, Singapore
Edwina A. Brown, Imperial College London, London, England, United Kingdom
Jason Tze Chern Lim, Vivance, Singapore
Sanjay Singh, Vivance, Singapore
Siti Noor Jamaluddin, Vivance, Singapore
Sheena Gow, Vivance, Singapore
Adam Russell, Vivance Inc, Los Angeles, California, United States
Mandar Gori, Vivance Inc, Los Angeles, California, United States
Martin J. Schreiber, Cleveland Clinic, Cleveland, Ohio, United States

Background

Peritoneal dialysis (PD) relies on regular delivery of large volume dialysate, posing logistical, storage and environmental burdens. Viva Komfort (VK) Automated PD (APD) system generates dialysate on demand from tap water, potentially eliminating bulk fluid deliveries. While the VK system has a companion cycler, the main aim was to evaluate preliminary safety and biocompatibility of the purified water prepared by on-demand dialysate generation (OnGen) at a modular level in a ESKD porcine PD model.

Methods

One male Sus scrofa pig (5/6 nephrectomy) underwent 28 days of APD. In Baseline (Day 1–14), standard Dianeal Low Cal 1.5% dialysate was used and in OnGen (Day 15–28), VK-generated 1.5% dextrose dialysis fluid; VK system infused purified tap water into a prefilled bag of concentrates that would produce dialysate similar to Dianeal Low Cal. In both phases, the same therapy dose was delivered (10h, 2L x 5 exchanges, with 2L Dianeal 1.5% last fill) via HomeChoice Pro as the VK companion cycler was still under development at the time of the study. Tap and purified water were tested on Day 1 prior to the start of the OnGen phase for sterility and endotoxin load. Serum biochemistry and hematology were assessed every 2 days and dialysate cell counts were assessed daily. Drain cultures were done at the start and end of each phase.

Results

The pig completed the 28–day study. The purified water produced by the VK met acceptable levels (Sterile, Endotoxin=0.01 EU/mL). No dialysate cultures turned positive through one week post study completion. Median (min–max) values of serum and dialysate parameters remained stable between the phases:

Conclusion

On–demand dialysate produced from tap water by the VK APD system was sterile, endotoxin–free, and well tolerated for 14 days in a large animal model, with stable inflammatory profiles and no infectious signals. These proof of concept data support further evaluation of the VK system in extended pre–clinical and forthcoming human studies.

		Baseline	Viva Komfort
Serum parameters	Urea (mmol/L)	11.9 (10.1 – 13.6)	10.2 (9.9 – 11.2)
	Creatinine (μmol/L)	435 (396 – 455)	449 (424 – 461)
	CRP (mg/L)	0.5 (0.4 – 2.0)	0.6 (0.5 – 0.7)
Dialysate parameters	Final Drain Cell count (10⁹/L)	0.002 (0.001 – 0.007)	0.001 (0.001 – 0.003)
Dialysate parameters	Turbidity (NTU)	1.3 (1.0 – 1.7)	1.5 (0.8 – 1.8)

Published abstract available at: doi: 10.1681/ASN.2025ksq026mv

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