Pilot Study of Wearable Artificial Kidney (WAK)

March 30, 2007 updated by: Royal Free Hampstead NHS Trust

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

This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • UCL Center for Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
fluid removal
patient satisfaction questionnaire
affect of treatment of cytokines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Free Hampstead NHS Trust

Collaborators

Xcorporeal

Investigators

  • Principal Investigator: Victor Gurra, MD, Cedars Sinai, Los Angeles, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 30, 2007

First Posted (Estimate)

April 2, 2007

Study Record Updates

Last Update Posted (Estimate)

April 2, 2007

Last Update Submitted That Met QC Criteria

March 30, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD7465
  • R&D Number 7465

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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