Kidney Week

Abstract: FR-OR23

First-in-Human Trial of the NeoKidney Portable Hemodialysis Device Sorbent System

Session Information

• Dialysis: What's New in Techniques and Management
  October 25, 2024 | Location: Room 8, Convention Center
  Abstract Time: 05:10 PM - 05:20 PM

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Lau, Titus W., National University Hospital, Singapore, Singapore

Titus W. Lau, MD

• Bluechel, Christian, Nextkidney, Singapore, Singapore

Christian Bluechel

• Khaopaibul, Paiboon, Nextkidney, Singapore, Singapore

Paiboon Khaopaibul

• Tan, Han Jie, Nextkidney, Singapore, Singapore

Han Jie Tan

• Toh, Yu En, Nextkidney, Singapore, Singapore

Yu En Toh

• Haroon, Sabrina, National University Hospital, Singapore, Singapore

Sabrina Haroon, MD

Background

The Neokidney^TM is a sorbent-based regenerative hemodialysis device intended for Short Daily Hemodialysis (SDHD). Unlike conventional hemodialysis (CHD), Neokidney^TM requires only 4.5L of dialysate by continuous regeneration of spent dialysate in a sorbent cartridge. The device has undergone pre-clinical testing with good treatment efficacy in animal studies.

Methods

The primary objective of this trial was to assess the clinical safety of a Neokidney^TM prototype (PAK HD). The secondary objective was to assess the therapeutic efficacy of Neokidney^TM sorbent therapy in comparison to CHD.

We conducted a cross-over clinical trial. Each patient received one CHD therapy and one Neokidney^TM sorbent therapy in the mid-week session in two consecutive weeks. The dialysis treatment prescription was similar for both therapies with 2 hours duration, use of high-flux dialyzer, a dialysate flow rate 300mL/min and a blood flow rate 300mL/min. Following two hours of therapy, all patients completed a further 2 hours of conventional dialysis therapy to receive a total of 4 hours of therapy to match their usual treatment time.

Results

A total of 3 patients were recruited. All patients tolerated and completed treatment with Neokidney^TM with no adverse events.
The sorbent cartridges removed approximately all urea, creatinine, and phosphate from spent dialysate during the dialysate regeneration process. The average plasma reduction ratios (RR) at 2 hours with Neokidney^TM for urea, creatinine and phosphate were 54%, 52% and 58%, respectively. In comparison, the RR at 2 hours CHD were 50%, 49% and 46%, respectively.

The average sodium concentration was at 139.0 mmol/L and 140.1mmol/L for regenerated and spent dialysate, respectively, thus maintained within ±0.5% of the concentration in spent dialysate, providing isonatremic dialysis. The dialysate bicarbonate concentration was maintained within ±4.7% of the concentration in spent dialysate. There were no significant differences in leukocyte count or complement concentration at the conclusion of both therapies.

Conclusion

The clinical trial demonstrated safety and efficacy of the Neokidney^TM sorbent system. The toxin removal with sorbent therapy was comparable to CHD and the regenerated dialysate composition accuracy met the design specifications to provide isonatremic dialysis with stable acid-base balance.

Funding

• Commercial Support – Nextkidney