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Pilot Study of Wearable Artificial Kidney (WAK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00454974
First Posted: April 2, 2007
Last Update Posted: April 2, 2007
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.
Collaborator:
Xcorporeal
Information provided by:
Royal Free Hampstead NHS Trust
  Purpose
This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.

Condition Intervention Phase
Renal Failure Device: Wearable artificial kidney Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Royal Free Hampstead NHS Trust:

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

Estimated Enrollment: 8
Study Start Date: March 2007
Study Completion Date: March 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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): NCT00454974


Locations
United Kingdom
UCL Center for Nephrology
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Royal Free Hampstead NHS Trust
Xcorporeal
Investigators
Principal Investigator: Victor Gurra, MD Cedars Sinai, Los Angeles, USA
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00454974     History of Changes
Other Study ID Numbers: RD7465
R&D Number 7465
First Submitted: March 29, 2007
First Posted: April 2, 2007
Last Update Posted: April 2, 2007
Last Verified: March 2007

Keywords provided by Royal Free Hampstead NHS Trust:
end stage renal failure
dialysis
wearable artificial kidney

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases


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