First-in-Human clinical trial with WEAKID peritoneal dialysis device completed

The First-In-Human (FIH) clinical study evaluating the WEAKID peritoneal dialysis (PD) device has successfully completed its final patient visit in December 2025, marking an important milestone for the development of next-generation PD therapy.

The study began in early January 2024 and enrolled 12 patients receiving peritoneal dialysis. Participants tested the WEAKID device over a two-week period, completing multiple treatments per participant while the team collected safety and efficacy data. In total, 66 WEAKID treatments were performed during the trial.

Safety outcomes

Across the entire study period, one serious adverse device effect (SADE) occurred. This event was attributed to an insufficient intraperitoneal volume prior to a WEAKID treatment, identified as a use error. Overall, continuous dialysate flow was well-tolerated by participants.

Preliminary efficacy signals

Early analyses indicate encouraging performance compared with traditional automated peritoneal dialysis (APD). When comparing 8-hour WEAKID treatments with sorbents to standard APD, preliminary results show:

• Increased plasma clearance:
  +26% creatinine, +20% phosphate, +12% potassium
• Increased MTAC (mass transfer area coefficient):
  +72% creatinine, +157% phosphate, +107% potassium

How WEAKID differs from standard APD

WEAKID introduces two key innovations:

1. Continuous dialysate flow in the abdomen rather than static dwells
2. Sorbent-based dialysate regeneration, reducing the total dialysate volume required

In addition, the WEAKID system is designed to be significantly more portable—approximately 4.5 kg compared with ~13.5 kg for many current PD devices.

Why this matters

By improving treatment efficiency and reducing dialysate needs, WEAKID aims to address current PD limitations and support better patient experience. The technology is also expected to reduce glucose exposure, which may help protect the peritoneal membrane and extend technique survival over time.

Next steps

Following further device optimization, the team plans to move toward a larger clinical trial to confirm safety and efficacy in a broader patient population.