Periodic Reporting for period 1 - CORDIAL (Clinical validation of a continuous flow peritoneal dialysis system, with dialysate regeneration)
Berichtszeitraum: 2021-07-01 bis 2022-12-31
The primary objective of the CORDIAL project is to perform the early clinical validation of a new peritoneal dialysis (PD) device called WEAKID (brand name).
The WEAKID system is innovative since instead of a stagnant filling of the abdominal cavity with dialysate as in traditional PD, WEAKID continuously circulates and regenerates dialysate using a sorbent system that adsorbs toxins. Hereby, a significant improvement in blood purification (2-3x) can be achieved in comparison to traditional PD while the number of dialysate exchanges can be reduced from 4-6 to 1 per day (less contamination risk). In addition, in traditional PD very high glucose concentrations are used for osmotic fluid removal that damage the peritoneal membrane. The new system slowly releases glucose so very high glucose concentrations are no longer needed, which helps to preserve the function of the peritoneal membrane and is expected to reduce peritonitis risk (inflammation of the membrane). The WEAKID system is an easy to use, portable/wearable machine that allows renal patients to dialyze conveniently at home or at work, independently from a fixed water supply. The system consists of a nighttime device (i.e. the main component of WEAKID treatment) and a daytime device (optional for patients who desire additional clearance).
The CORDIAL project includes the first-in-human (FIH) investigation (several days of WEAKID treatment in the hospital) and a subsequent crossover feasibility/pivotal (CF) investigation (one month of treatment with WEAKID treatment at home followed by standard PD or vice versa) to demonstrate the safety and performance of the WEAKID system.
In addition to the clinical validation, the project includes usability testing, manufacturing and further development of the devices, assessing implementation conditions, patient experience and quality of life, and an early health technology assessment.
The WEAKID system is innovative since instead of a stagnant filling of the abdominal cavity with dialysate as in traditional PD, WEAKID continuously circulates and regenerates dialysate using a sorbent system that adsorbs toxins. Hereby, a significant improvement in blood purification (2-3x) can be achieved in comparison to traditional PD while the number of dialysate exchanges can be reduced from 4-6 to 1 per day (less contamination risk). In addition, in traditional PD very high glucose concentrations are used for osmotic fluid removal that damage the peritoneal membrane. The new system slowly releases glucose so very high glucose concentrations are no longer needed, which helps to preserve the function of the peritoneal membrane and is expected to reduce peritonitis risk (inflammation of the membrane). The WEAKID system is an easy to use, portable/wearable machine that allows renal patients to dialyze conveniently at home or at work, independently from a fixed water supply. The system consists of a nighttime device (i.e. the main component of WEAKID treatment) and a daytime device (optional for patients who desire additional clearance).
The CORDIAL project includes the first-in-human (FIH) investigation (several days of WEAKID treatment in the hospital) and a subsequent crossover feasibility/pivotal (CF) investigation (one month of treatment with WEAKID treatment at home followed by standard PD or vice versa) to demonstrate the safety and performance of the WEAKID system.
In addition to the clinical validation, the project includes usability testing, manufacturing and further development of the devices, assessing implementation conditions, patient experience and quality of life, and an early health technology assessment.
The project started 1st of July 2021. Devices and cartridges were manufactured for the FIH trial. Successful usability sessions were held in the Netherlands, Italy and Spain with patients and nurses. The Standard Research File for the FIH trial was finalized (including the Investigational Medical Device Dossier) and the necessary legal arrangements were made. Submission to the Dutch competent authority for approval for the FIH trial was done on the 21st of March, 2023, who handed it over to the REC on the 27th of March. During the preparations an advisory board and ethics board have been involved. Despite all efforts, due to significant delays in the delivery of critical components (fluids, fluidic parts and electronic components) due to among others the COVID pandemic and the Ukraine war, withdrawal of the fluid and conditioning supplier and subsequent delays in required final testing, the FIH investigation has not yet been started (envisioned delay of at least 16 months for ‘first patient in’).
Besides the preparations for the FIH investigation, an international dialysis health care landscape analysis was performed based on interviews with stakeholders in six European countries and a thorough literature search, providing useful insight in dialysis epidemiology and costs, unmet needs for PD, dialysis providers and market entry and reimbursement strategies Europe. In addition, several dissemination activities were initiated (project website, conference presentations).
Besides the preparations for the FIH investigation, an international dialysis health care landscape analysis was performed based on interviews with stakeholders in six European countries and a thorough literature search, providing useful insight in dialysis epidemiology and costs, unmet needs for PD, dialysis providers and market entry and reimbursement strategies Europe. In addition, several dissemination activities were initiated (project website, conference presentations).
The WEAKID system will overcome the drawbacks of existing home dialysis therapies by offering a portable/wearable system with high clearance and less complications/improved technique survival, that is easy to use, without requiring a complex infrastructure. WEAKID will keep dialysis affordable for the future with a considerable impact on patients’ health and quality of life. The innovative potential is supported among others by the European Renal Association, European Kidney Health Alliance, Dutch Kidney Foundation, Italian Nephrology Society and the clinicians and patients from the advisory board. Despite the delay, we still aim to complete the planned clinical validation work from TRL5 to TRL7 and make progress on the exploitation and future availability of the innovative WEAKID device for patients.