Pilot Study of Wearable Artificial Kidney

Phase 1

Completed

• Conditions: Renal Failure

• Registration Number: NCT00454974
• Lead Sponsor: Royal Free Hampstead NHS Trust

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 Timeline

• Status Verified: 2007-03
• Study Start: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2007-03-29
• Study First Submitted QC: 2007-03-30
• Last Update Submitted: 2007-03-30
• Study First Posted: 2007-04-02
• Last Update Posted: 2007-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
patient satisfaction questionnaire
affect of treatment of cytokines
fluid removal

Trial Locations

Locations (1)

UCL Center for Nephrology; 🇬🇧 London, United Kingdom