24 Hour Use of the Wearable Artificial Kidney (WAK US 1)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||First 24 Hour Human Trial of the Wearable Artificial Kidney|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 hours ]
- Subject vital signs as a Measure of Safety and Tolerability [ Time Frame: 24 hours ]
- Satisfaction survey as a Measure of Safety and Tolerability [ Time Frame: Post Treatment ]
- Blood creatinine as a Measure of Safety and Tolerability [ Time Frame: 24 hours ]
- Dialysate toxin load as a Measure of Safety and Tolerability [ Time Frame: 24 hours ]
- Blood electrolytes as a Measure of Safety and Tolerability [ Time Frame: 24 Hours ]
- Blood urea levels [ Time Frame: 24 hours ]
- Dialysate Urea Levels [ Time Frame: 24 hours ]
- Blood creatinine levels [ Time Frame: 24 hours ]
- Dialysate creatinine levels [ Time Frame: 24 Hours ]
- Volume of spent dialysate [ Time Frame: 24 Hours ]
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||May 2016|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: WAK Treatment
Use of experimental device.
Device: WAK Treatment
Hemodialysis with WAK device.
Subjects will undergo 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02280005
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195U|
|Principal Investigator:||Jonathan Himmelfarb, MD||University of Washington|