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NCT00454974 Clinical Trial

Pilot Study of Wearable Artificial Kidney

Renal Failure Clinical Trial

— WAK  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00454974
Other study ID # RD7465
Secondary ID R&D Number 7465
Status Completed
Phase Phase 1
First received March 29, 2007
Last updated March 30, 2007
Start date March 2007
Est. completion date March 2007

Study information
Verified date March 2007
Source Royal Free Hampstead NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Device:
• Wearable artificial kidney

Locations
Country Name City State
United Kingdom UCL Center for Nephrology London

Sponsors (2)
Lead Sponsor Collaborator
Royal Free Hampstead NHS Trust Xcorporeal

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary urea, potassium, phosphate and B2M clearances
Primary safety - cardiovascular,no hemolysis, bleeding, infection
Primary no ammonia generation from sorbents, control of acid base balance
Secondary fluid removal
Secondary patient satisfaction questionnaire
Secondary affect of treatment of cytokines
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