- Although dialysis is lifesaving, not much has changed with the therapy since it was first available to end-stage renal disease patients in 1960.
- Most patients dialyze in a center three times a week. Many don’t feel well with that amount of dialysis and wish they weren’t restricted to an in-center dialysis schedule.
- This trial tested an 11-pound wearable device that provided continual dialysis to patients with end-stage renal disease.
- Seven patients tested the device and most wore it for a full 24 hours.
- This trial provided proof of concept that a wearable device for dialysis could work for many kidney patients. It was well-received by patients, providing them more freedom and allowing them to be much less restrictive with their diet.
Participants underwent 24 hours in-hospital treatment with the Wearable Artificial Kidney (WAK). Up to 10 subjects with ESRD will complete the protocol in its entirety. The objective of this protocol is to provide additional preliminary data supporting the hypothesis that the WAK safely and effectively delivers dialysis therapy that is at least equal to the current standard of care for treatment of ESRD using conventional machines for thrice weekly hemodialysis treatments. These objectives would be accomplished by absence of adverse events during treatment with the WAK, along with effective removal of fluid and solutes at least equal to those delivered with conventional currently used dialysis machines. The WAK will be the only investigational device used in this study. The reason for this trial is to advance the eventual approval of this device to be legally commercialized as it potentially may respond to the unmet public health needs to improve outcomes and reduce costs in the treatment of ESRD patients.