A team of scientists at the University of California, Los Angeles, invented a Wearable Artificial Kidney device, designed to untether patients from large dialysis machines. The device can give patients with end-stage renal failure a degree of mobility and freedom for such routine activities as walking or shopping while their dialysis runs. Safety and performance testing is now set to begin at the University of Washington (UW), Seattle. The clinical trial will be the first human study in the US to be conducted on the device.
The Wearable Artificial Kidney (WAK) is a miniaturized dialysis machine that can be worn on the body. The carrier resembles a tool belt and the device connects to a patient via a catheter. Unlike current portable or stationary dialysis machines, it can run continuously on batteries and is not plugged into an electrical outlet or attached to a water pipe. The present version weighs about 10 pounds, but, the researchers say that future modifications could make it lighter and more streamlined.
The WAK has been in development for more than a decade. The agreement with the FDA and the UW Institutional Review Board for the pending safety and performance study includes strict criteria for inclusion of patients, and several other restrictions on eligibility. Up to 16 patients will be accepted, with the goal that 10 will complete the full trial.
Testing will take place in an inpatient hospital setting at UW Medical Center in Seattle. Blood samples will be drawn periodically throughout the 24-hour test. Other clinical measurements will be made during and after treatment with the device. The patient volunteers then will be observed for at least 28 days. Due to logistics, the Seattle team will recruit local patients only.
The safety and performance of the device must first be confirmed before any additional studies are held. The device will not be generally available for patients until it is fully evaluated, so the roll-out is not yet slated. In the future, if preliminary tests go well, researchers hope to determine if any benefits arise from slow, steady dialysis to mimic the natural, around-the-clock clearance of normal kidneys.