NCT02280005

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 per week for end-stage renal disease (ESRD) via an indwelling tunneled catheter will be studied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

September 19, 2014

Last Update Submit

July 14, 2017

Conditions

End Stage Renal Disease

Keywords

DialysisRenal FailureWearableArtificial KidneyHemodialysis

Outcome Measures

Primary Outcomes (6)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    24 hours

  • Subject vital signs as a Measure of Safety and Tolerability

    24 hours

  • Satisfaction survey as a Measure of Safety and Tolerability

    Post Treatment

  • Blood creatinine as a Measure of Safety and Tolerability

    24 hours

  • Dialysate toxin load as a Measure of Safety and Tolerability

    24 hours

  • Blood electrolytes as a Measure of Safety and Tolerability

    24 Hours

Secondary Outcomes (5)

  • Blood urea levels

    24 hours

  • Dialysate Urea Levels

    24 hours

  • Blood creatinine levels

    24 hours

  • Dialysate creatinine levels

    24 Hours

  • Volume of spent dialysate

    24 Hours

Study Arms (1)

WAK Treatment

EXPERIMENTAL

Use of experimental device.

Device: WAK Treatment

Interventions

WAK TreatmentDEVICE

Hemodialysis with WAK device.

WAK Treatment

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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\*
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195U, United States

Location

Related Publications (1)

  • 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):e86397. doi: 10.1172/jci.insight.86397.

    PMID: 27398407DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan Himmelfarb, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations

US(1)