- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02280005
24 Hour Use of the Wearable Artificial Kidney (WAK US 1)
First 24 Hour Human Trial of the Wearable Artificial Kidney
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195U
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient willing and competent to sign the approved informed consent.
- Patient must be at least 21 years of age or older.*
- Patient must weigh between 45 and 100kg, inclusive.*
- Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 3 times a week for at least 3 months prior to being enrolled.*
- Vascular access must be through a functioning double lumen catheter with no thrombolytic therapy or clotting of the catheter within the past 4 weeks.*
- Willing to comply with the requirements of experimental treatment with the WAK for up to 24 hours.
- Expected survival of no less than 6 months.*
- Consent to allow review of their medical records by the investigators, and monitors.
- Fluency in English
- Hemoglobin level ≥ 9.0 g/dL prior to WAK treatment
Exclusion Criteria:
• Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.**
History (within the 12 weeks prior to the study) of cardiovascular events including:*
- Unstable angina
- Myocardial Infarction
- Stroke
- Clinical Significant Arrhythmia
- Life threatening arrhythmia within the past 30 days*
- Severe intradialytic hypotension within the last 30 days*
- Shock within the last 30 days*
- Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient*
- Seizure disorder requiring active treatment for a seizure episode during the last 6 months*
- Major Surgery (excluding vascular access surgery) within the past 30 days *
- Currently receiving intravenous antibiotic therapy for systemic infection*
- Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days*
- Active bleeding*
- Hematological disease (e.g. malignancies, hemolytic anemia, thrombocytopenia), and other conditions that may interfere of confuse the data obtained from this trial.*
- Current enrollment in another investigational device or drug trial.**
- Subject is pregnant (e.g., positive HCG test) or is breast feeding.
- Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.*
- Allergy to heparin or ethylene oxide.*
- Hypertension deemed uncontrolled, at the discretion of the investigator, within the past 30 days.*
Has an implantable electronic device (e.g. pacemaker)*
- As documented in patient medical history (see attached). **Patient self-report.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WAK Treatment
Use of experimental device.
|
Hemodialysis with WAK device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 24 hours
|
24 hours
|
Subject vital signs as a Measure of Safety and Tolerability
Time Frame: 24 hours
|
24 hours
|
Satisfaction survey as a Measure of Safety and Tolerability
Time Frame: Post Treatment
|
Post Treatment
|
Blood creatinine as a Measure of Safety and Tolerability
Time Frame: 24 hours
|
24 hours
|
Dialysate toxin load as a Measure of Safety and Tolerability
Time Frame: 24 hours
|
24 hours
|
Blood electrolytes as a Measure of Safety and Tolerability
Time Frame: 24 Hours
|
24 Hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood urea levels
Time Frame: 24 hours
|
24 hours
|
Dialysate Urea Levels
Time Frame: 24 hours
|
24 hours
|
Blood creatinine levels
Time Frame: 24 hours
|
24 hours
|
Dialysate creatinine levels
Time Frame: 24 Hours
|
24 Hours
|
Volume of spent dialysate
Time Frame: 24 Hours
|
24 Hours
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WAK Seattle
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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