Pilot Study of Wearable Artificial Kidney (WAK)

This study has been completed.
Sponsor:
Collaborator:
Xcorporeal
Information provided by:
Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:
NCT00454974
First received: March 29, 2007
Last updated: March 30, 2007
Last verified: March 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: March 29, 2007
Last Updated: March 30, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014