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24 Hour Use of the Wearable Artificial Kidney (WAK US 1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02280005
First Posted: October 31, 2014
Last Update Posted: July 18, 2017
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.
Collaborators:
University of Washington
Wearable Artificial Kidney Foundation
Information provided by (Responsible Party):
Blood Purification Technologies, Inc.
  Purpose
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 per week for end-stage renal disease (ESRD) via an indwelling tunneled catheter will be studied.

Condition Intervention
End Stage Renal Disease Device: WAK Treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First 24 Hour Human Trial of the Wearable Artificial Kidney

Resource links provided by NLM:


Further study details as provided by Blood Purification Technologies, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Actual Study Start Date: October 2014
Study Completion Date: May 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WAK Treatment
Use of experimental device.
Device: WAK Treatment
Hemodialysis with WAK device.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195U
Sponsors and Collaborators
Blood Purification Technologies, Inc.
University of Washington
Wearable Artificial Kidney Foundation
Investigators
Principal Investigator: Jonathan Himmelfarb, MD University of Washington
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Blood Purification Technologies, Inc.
ClinicalTrials.gov Identifier: NCT02280005     History of Changes
Other Study ID Numbers: WAK Seattle
First Submitted: September 19, 2014
First Posted: October 31, 2014
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Blood Purification Technologies, Inc.:
Dialysis
Renal Failure
Wearable
Artificial Kidney
Hemodialysis

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases