News overview

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

The First-In-Human study started at the beginning of January, 2024. During this study, patients on PD tested the new device during two weeks (six WEAKID treatments per participant) and safety and efficacy data were collected. In total, 12 patients have been treated with the WEAKID device during the study and the final study visit occurred in December, 2025. 66 WEAKID treatments were completed during the trial. One SADE occurred throughout the entire study period caused by an insufficient intraperitoneal volume prior to the WEAKID treatment (i.e., a use error). The continuous flow was well-tolerated by participants. Preliminary efficacy analyses show an increased plasma clearance (+26% for creatinine, +20% for phosphate, and +12% for potassium) and MTAC (+72% for creatinine, +157% for phosphate, and +107% for potassium) when comparing 8-hour WEAKID treatments with sorbents to traditional APD.

Sorbent technology for sustainable dialysis

The WEAKID sorbent technology could be interesting to reduce dialysis water consumption. Last week, Karin Gerritsen presented innovative ideas in dialysis on the KDIGO Controversies Conference on Green Dialysis in Berlin.

The dialysis users are the ultimate experts

Direct involvement of dialysis users is essential for the succes of this project and crucial for the development of the WEAKID device! Therefore we appreciate that already 65 surveys have been completed and we expect to reach our goal of 100 this summer. We will also soon plan the interactive focus groups: the first one will take place in the Netherlands, with similar sessions later in Spain and Italy.

The FIH trial continues in Madrid with the 6th participant

In February 2025, the 6th participant in the First-in-Human trial will be included at the Hospital Universitario la Paz, in Madrid.

The FIH trial continues in Modena with the 5th participant

In September 2024, the 5th participant in the First-in-Human trial will be included at the University Hospital of Modena.

Approval to start FIH trial in Modena and Madrid

The sites in Modena (Italy) and Madrid (Spain) have received approval to execute the First-in-Human CORDIAL trial.

The CORDIAL survey for patients to investigate the preferences for new peritoneal dialysis devices is now available in English, Dutch, Spanish and Italian.

CORDIAL survey available in English and Dutch

The CORDIAL survey for patients to investigate the preferences for new peritoneal dialysis devices is now available in English and Dutch.

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