Periodic Reporting for period 2 - CORDIAL (Clinical validation of a continuous flow peritoneal dialysis system, with dialysate regeneration)
Okres sprawozdawczy: 2023-01-01 do 2024-06-30
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 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) to demonstrate the safety and performance of the WEAKID system. Initially also a second trial was planned within this project; however, 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 a critical supplier and subsequent delays in required final testing, the focus in this project will be on the FIH trial. The subsequent trial will be planned at a later stage.
In addition to the clinical validation, the project includes usability testing, manufacturing and final acceptance tests of the devices, assessing implementation conditions, patient experience and quality of life, and an early health technology assessment.
The CORDIAL project includes the first-in-human (FIH) investigation (several days of WEAKID treatment in the hospital) to demonstrate the safety and performance of the WEAKID system. Initially also a second trial was planned within this project; however, 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 a critical supplier and subsequent delays in required final testing, the focus in this project will be on the FIH trial. The subsequent trial will be planned at a later stage.
In addition to the clinical validation, the project includes usability testing, manufacturing and final acceptance tests 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. Upon completion of the pre-clinical validation, approval for the FIH was initially obtained for UMC Utrecht (NL) and the first four patients successfully completed the intervention in the first half of 2024. In the meanwhile, approval was obtained for the other sites, UNIMORE (Modena, Italy) and SERMAS/FIBHULP (Madrid, Spain) in August 2024 and the remaining eight patients will be included after the summer of 2024.
Besides the execution of the FIH trial, work has been done to analyse the economic aspects of the future introduction and use of the device, providing useful insight in dialysis epidemiology and costs, unmet needs for PD, dialysis providers and market entry and reimbursement strategies Europe. Also a survey has been opened for PD patients, which is accessible via the project’s website. In the meanwhile, the device and work is being demonstrated at various conferences and other events.
Besides the execution of the FIH trial, work has been done to analyse the economic aspects of the future introduction and use of the device, providing useful insight in dialysis epidemiology and costs, unmet needs for PD, dialysis providers and market entry and reimbursement strategies Europe. Also a survey has been opened for PD patients, which is accessible via the project’s website. In the meanwhile, the device and work is being demonstrated at various conferences and other events.
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. In this project we complete the necessary steps in the clinical validation and exploitation to make the innovative WEAKID device available for patients.