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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014