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OpenTrials
Completed

NCT Number: NCT00454974

Pilot Study of Wearable Artificial Kidney

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

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Key information

Conditions

Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCL Center for Nephrology

London, NW3 2QG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable artificial kidney

Device

Primary outcomes

  1. urea, potassium, phosphate and B2M clearances

  2. safety - cardiovascular,no hemolysis, bleeding, infection

  3. no ammonia generation from sorbents, control of acid base balance

Secondary outcomes

  1. fluid removal

  2. patient satisfaction questionnaire

  3. affect of treatment of cytokines

Sponsors and collaborators

Lead sponsor

Royal Free Hampstead NHS Trust

Other

Collaborators

  • Xcorporeal

Registry information

Official study title

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

Acronym: WAK

Important dates

Study start
2007
Study completion
2007
First posted
Apr 2, 2007
Registry last updated
Apr 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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