Abstract: TH-OR115
Efficacy and Safety of the Neokidney Portable Hemodialysis System: Preliminary Phase 1 and 2 Results of the RENEW-HD Trial
Session Information
- Late-Breaking Research Orals: Dialysis and Transplantation
October 22, 2026 | Location: Four Seasons Ballroom 2, Convention Center
Abstract Time: 05:06 PM - 05:18 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Bolhuis, Dian Petra, Universitair Medisch Centrum Utrecht, Utrecht, UT, Netherlands
- Bach, Dieter, Nextkidney BV, Bussum, NH, Netherlands
- Bluechel, Christian, Nextkidney SA, Lausanne, Switzerland
- Conan, Christophe, Nextkidney SA, Lausanne, Switzerland
- Ficheux, Maxence, Centre Hospitalier Universitaire de Caen Normandie, Caen, Normandy, France
- Goffin, Eric, Cliniques universitaires Saint-Luc, Brussels, Belgium
- Rotmans, Joris I., Leids Universitair Medisch Centrum, Leiden, ZH, Netherlands
- Logtenberg, Susan J., Dianet, Utrecht, UT, Netherlands
- Gerritsen, Karin G.F., Universitair Medisch Centrum Utrecht, Utrecht, UT, Netherlands
Background
Conventional hemodialysis (HD) requires substantial infrastructure and water, limiting patient mobility. Neokidney is a portable (~13kg) system designed for short (2h), frequent HD using only 4.5L of dialysate regenerated by sorbents. RENEW-HD evaluates the efficacy and safety of the Neokidney system.
Methods
RENEW-HD is the pivotal, prospective, open-label, single-arm investigation of the Neokidney system in adults on maintenance HD in 4 European centers. In Phase 1, four participants underwent assisted in-center HD with Neokidney for up to 11 sessions over 3 weeks. In the ongoing Phase 2, participants receive assisted Neokidney HD in-center for up to 30 days (4–7 sessions/week), with a target of 500 sessions. The primary efficacy endpoint is mean single-pool Kt/V (spKt/V). Adequate performance is defined as a lower bound of the two-sided 95% confidence interval (CI) ≥0.60. Additional outcomes include serious adverse device effects (SADEs), vital and biochemical parameters, and ultrafiltration (UF) accuracy.
Results
As of August 31st, 2026, 29 participants were included and completed 474 Neokidney sessions (95% of planned Phase 1&2 sessions). No SADEs or device deficiencies with potential to cause a serious adverse event occurred. Vital parameters and blood biochemistry, including sodium and bicarbonate, remained generally stable over the 4-week treatment period, indicating adequate fluid, electrolyte and acid/base control. Sorbent exhaustion occurred only once, at the end of a session in which estimated urea removal exceeded the system's specified maximum urea-removal capacity. This was correctly detected by the device and there was no occurrence of hyperammonemia in any of the 474 sessions. Preliminary trending will be disclosed once the full set of data is available.
Conclusion
Near-complete Phase 1&2 results of RENEW-HD indicate that short frequent hemodialysis with the Neokidney system was performed safely, with no serious adverse device effects, and delivered a dialysis dose consistent with current adequacy targets. The findings further support the feasibility of the Neokidney system. The full set of results is expected to be available by October 1st, 2026.
Funding
- Commercial Support – Nextkidney B.V.