Pilot Study of Wearable Artificial Kidney - Full Text View

Pilot Study of Wearable Artificial Kidney (WAK)

This study has been completed.

First Received: March 29, 2007 Last Updated: March 30, 2007 History of Changes

Sponsors and Collaborators:	Royal Free Hampstead NHS Trust Xcorporeal
Information provided by:	Royal Free Hampstead NHS Trust
ClinicalTrials.gov Identifier:	NCT00454974

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

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:

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;149:325-33.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2009 Apr 19.

Study ID Numbers:	RD7465, R&D Number 7465
Study First Received:	March 29, 2007
Last Updated:	March 30, 2007
ClinicalTrials.gov Identifier:	NCT00454974 History of Changes
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

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on September 10, 2009