Portable dialysis system achieves clinical validation
Kidney failure is often treated with in-clinic haemodialysis, in which a patient is connected to a machine that filters their blood to remove waste products, toxins and excess fluids. This lifesaving treatment, while critical, has a considerable impact on quality of life. “Patients are usually connected to a dialysis machine three times a week for up to four hours, and often have to spend six hours in the hospital at a time,” notes CORDIAL(opens in new window) project member Frank Simonis from Nanodialysis in the Netherlands. “This is difficult to combine with a normal working life. In addition, blood values change dramatically in the space of four hours, which can leave a patient feeling tired.”
Pros and cons of peritoneal dialysis
Another option is peritoneal dialysis, which uses the lining of the abdomen as a filter. Here, blood releases toxins through the peritoneal membrane into a special cleansing fluid called a peritoneal dialysate, which is introduced into the abdomen via a catheter. Once filled with filtered waste, the fluid is removed via the catheter and disposed of. While this method enables patients to treat themselves at home – and therefore better combine it with a normal life – it nonetheless comes with drawbacks. For a start, it is less efficient than haemodialysis, and therefore less suitable for patients without residual kidney function. In addition, while glucose is needed in the dialysate to attract and remove excess fluid, this can damage the peritoneal membrane. “After several years, patients might need to go back on haemodialysis,” says Simonis.
Clinical trials of portable dialysis device
The CORDIAL project sought to tackle some of these drawbacks by bringing a new device to clinical trial. A previous EU-funded project called WEAKID had helped the consortium to develop a new, portable peritoneal dialysis prototype designed to efficiently remove toxins and excess water at lower glucose levels. “Instead of the normal practice of filling and removing fluid, this system recirculates dialysate continuously,” explains Simonis. “This continuous circulation, along with absorbents for additional capacity, enables the efficient removal of toxins and excess fluid at lower glucose concentrations.” The prototype has been previously tested in lab and in animal models. CORDIAL was launched to enable the team to take the next step forward – first-in-human studies. The trials were conducted at three European hospitals – Utrecht, Modena and Madrid – which were coordinated by Karin Gerritsen from the University Medical Centre Utrecht(opens in new window). A total of 12 patients were involved.
Limited redesign followed by further clinical trials
A total of 66 treatments were completed during the trial. While some minor adverse effects were recorded, the continuous flow mechanism was well-tolerated by all participants. “Overall, the WEAKID device was shown to be safe,” adds Gerritsen. “Efficacy data look promising, with a nice increase in solute transfer capacity across the peritoneal membrane and increase in solute clearance.” Next steps are likely to include a limited redesign of the device based on project outcomes, including usability improvements. Further clinical trials will then be needed in order to examine longer-term safety and efficacy of the redesigned WEAKID device. This will help to secure CE approval and move towards eventual commercialisation.