Pilot Study of Wearable Artificial Kidney (WAK)

Royal Free Hampstead NHS Trust

Status and phase: Completed; Phase 1

Conditions: Renal Failure

Treatments: Device: Wearable artificial kidney

Study type: Interventional

Funder types: Other

Identifiers

NCT00454974

RD7465

R&D Number 7465

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)