24 Hour Use of the Wearable Artificial Kidney

Completed · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT02280005

Run by

Blood Purification Technologies, Inc.

People needed

8

Starts

2014-10-01

Expected to finish

2016-05-01

Last updated by the study team

2017-07-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• • 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.

Where it is running

• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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