Status:
COMPLETED
24 Hour Use of the Wearable Artificial Kidney
Lead Sponsor:
Blood Purification Technologies, Inc.
Collaborating Sponsors:
University of Washington
Wearable Artificial Kidney Foundation
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This is a prospective, interventional study designed to provide preliminary data on the human use of the WAK. Up to 10 subjects currently receiving intermittent hemodialysis (HD) treatment three times...
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 ...
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02280005
Start Date
October 1 2014
End Date
May 1 2016
Last Update
July 18 2017
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98195U