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

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ClinicalTrials.gov Identifier: NCT02280005
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : July 18, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

September 19, 2014
October 31, 2014
July 18, 2017
October 2014
May 2015   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT02280005 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
24 Hour Use of the Wearable Artificial Kidney
First 24 Hour Human Trial of the Wearable Artificial Kidney
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End Stage Renal Disease
Device: WAK Treatment
Hemodialysis with WAK device.
Experimental: WAK Treatment
Use of experimental device.
Intervention: Device: WAK Treatment
Gura V, Rivara MB, Bieber S, Munshi R, Smith NC, Linke L, Kundzins J, Beizai M, Ezon C, Kessler L, Himmelfarb J. A wearable artificial kidney for patients with end-stage renal disease. JCI Insight. 2016 Jun 2;1(8). pii: e86397.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 2016
May 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02280005
WAK Seattle
Yes
Not Provided
Not Provided
Blood Purification Technologies, Inc.
Blood Purification Technologies, Inc.
  • University of Washington
  • Wearable Artificial Kidney Foundation
Principal Investigator: Jonathan Himmelfarb, MD University of Washington
Blood Purification Technologies, Inc.
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP