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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 29, 2007

Last Updated Date

March 30, 2007

Start Date ^ICMJE

March 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00454974 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

fluid removal
patient satisfaction questionnaire
affect of treatment of cytokines

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pilot Study of Wearable Artificial Kidney

Official Title ^ICMJE

Preliminary Study to Assess the Safety and Efficacy of a Wearable Artificial Kidney Device for the Treatment of Patients With Endstage Renal Failure

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Renal Failure

Intervention ^ICMJE

Device: Wearable artificial kidney

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00454974

Other Study ID Numbers ^ICMJE

RD7465, R&D Number 7465

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Royal Free Hampstead NHS Trust

Collaborators ^ICMJE

Xcorporeal

Investigators ^ICMJE

Principal Investigator:

Victor Gurra, MD

Cedars Sinai, Los Angeles, USA

Information Provided By

Royal Free Hampstead NHS Trust

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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