24 Hour Use of the Wearable Artificial Kidney (WAK US 1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02280005|
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : July 18, 2017
|Condition or disease||Intervention/treatment|
|End Stage Renal Disease||Device: WAK Treatment|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||First 24 Hour Human Trial of the Wearable Artificial Kidney|
|Actual Study Start Date :||October 2014|
|Primary Completion Date :||May 2015|
|Study Completion Date :||May 2016|
Experimental: WAK Treatment
Use of experimental device.
Device: WAK Treatment
Hemodialysis with WAK device.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280005
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195U|
|Principal Investigator:||Jonathan Himmelfarb, MD||University of Washington|