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Pilot Study of Wearable Artificial Kidney (WAK)

Primary Purpose

Renal Failure

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Wearable artificial kidney
Sponsored by
Royal Free Hampstead NHS Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring end stage renal failure, dialysis, wearable artificial kidney

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • End stage renal failure
  • Regular haemodialysis
  • Cardiovascular stability
  • Stable vascular access

Exclusion Criteria:

  • Allergy to heparin or ethylene oxide
  • Recent cardiovascular or neurological event
  • Unable to provide informed consent
  • Age < 18

Sites / Locations

  • UCL Center for Nephrology

Outcomes

Primary Outcome Measures

urea, potassium, phosphate and B2M clearances
safety - cardiovascular,no hemolysis, bleeding, infection
no ammonia generation from sorbents, control of acid base balance

Secondary Outcome Measures

fluid removal
patient satisfaction questionnaire
affect of treatment of cytokines

Full Information

First Posted
March 29, 2007
Last Updated
March 30, 2007
Sponsor
Royal Free Hampstead NHS Trust
Collaborators
Xcorporeal
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1. Study Identification

Unique Protocol Identification Number
NCT00454974
Brief Title
Pilot Study of Wearable Artificial Kidney
Acronym
WAK
Official Title
Preliminary Study to Assess the Safety and Efficacy of a Wearable Artificial Kidney Device for the Treatment of Patients With Endstage Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Free Hampstead NHS Trust
Collaborators
Xcorporeal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.
Detailed Description
This is a pilot study to evaluate the clearances, tolerability and safety of a wearable artificial kidney device for treating patients with chronic kidney failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
end stage renal failure, dialysis, wearable artificial kidney

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Wearable artificial kidney
Primary Outcome Measure Information:
Title
urea, potassium, phosphate and B2M clearances
Title
safety - cardiovascular,no hemolysis, bleeding, infection
Title
no ammonia generation from sorbents, control of acid base balance
Secondary Outcome Measure Information:
Title
fluid removal
Title
patient satisfaction questionnaire
Title
affect of treatment of cytokines

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: End stage renal failure Regular haemodialysis Cardiovascular stability Stable vascular access Exclusion Criteria: Allergy to heparin or ethylene oxide Recent cardiovascular or neurological event Unable to provide informed consent Age < 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Gurra, MD
Organizational Affiliation
Cedars Sinai, Los Angeles, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCL Center for Nephrology
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15876856
Citation
Gura V, Beizai M, Ezon C, Polaschegg HD. Continuous renal replacement therapy for end-stage renal disease. The wearable artificial kidney (WAK). Contrib Nephrol. 2005;149:325-333. doi: 10.1159/000085694.
Results Reference
background
PubMed Identifier
19376616
Citation
Gura V, Davenport A, Beizai M, Ezon C, Ronco C. Beta2-microglobulin and phosphate clearances using a wearable artificial kidney: a pilot study. Am J Kidney Dis. 2009 Jul;54(1):104-11. doi: 10.1053/j.ajkd.2009.02.006. Epub 2009 Apr 19.
Results Reference
derived

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Pilot Study of Wearable Artificial Kidney

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