title: A wearable artificial kidney for patients with end-stage renal disease.
abstract: BACKGROUND
  Stationary hemodialysis machines hinder mobility and limit activities of daily life during dialysis treatments. New hemodialysis technologies are needed to improve patient autonomy and enhance quality of life.
  
  
  METHODS
  We conducted a FDA-approved human trial of a wearable artificial kidney, a miniaturized, wearable hemodialysis machine, based on dialysate-regenerating sorbent technology. We aimed to determine the efficacy of the wearable artificial kidney in achieving solute, electrolyte, and volume homeostasis in up to 10 subjects over 24 hours.
  
  
  RESULTS
  During the study, all subjects remained hemodynamically stable, and there were no serious adverse events. Serum electrolytes and hemoglobin remained stable over the treatment period for all subjects. Fluid removal was consistent with prescribed ultrafiltration rates. Mean blood flow was 42 ± 24 ml/min, and mean dialysate flow was 43 ± 20 ml/min. Mean urea, creatinine, and phosphorus clearances over 24 hours were 17 ± 10, 16 ± 8, and 15 ± 9 ml/min, respectively. Mean β2-microglobulin clearance was 5 ± 4 ml/min. Of 7 enrolled subjects, 5 completed the planned 24 hours of study treatment. The trial was stopped after the seventh subject due to device-related technical problems, including excessive carbon dioxide bubbles in the dialysate circuit and variable blood and dialysate flows.
  
  
  CONCLUSIONS
  Treatment with the wearable artificial kidney was well tolerated and resulted in effective uremic solute clearance and maintenance of electrolyte and fluid homeostasis. These results serve as proof of concept that, after redesign to overcome observed technical problems, a wearable artificial kidney can be developed as a viable novel alternative dialysis technology.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02280005.
  
  
  BACKGROUND
  The Wearable Artificial Kidney Foundation and Blood Purification Technologies Inc.
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, California, USA.|David Geffen School of Medicine at UCLA, UCLA, Los Angeles, California, USA.
authors.forename: Victor
authors.initials: V
authors.lastname: Gura
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, Washington, USA.
authors.forename: Matthew B
authors.initials: MB
authors.lastname: Rivara
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, Washington, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Bieber
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, Washington, USA.|Division of Nephrology, Department of Pediatrics, Seattle Children's Hospital and University of Washington, Seattle, Washington, USA.
authors.forename: Raj
authors.initials: R
authors.lastname: Munshi
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, Washington, USA.|University of Washington Medical Center, Seattle, Washington, USA.
authors.forename: Nancy Colobong
authors.initials: NC
authors.lastname: Smith
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, Washington, USA.
authors.forename: Lori
authors.initials: L
authors.lastname: Linke
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, Washington, USA.
authors.forename: John
authors.initials: J
authors.lastname: Kundzins
authors.affiliation: Blood Purification Technologies Inc., Beverly Hills, California, USA.
authors.forename: Masoud
authors.initials: M
authors.lastname: Beizai
authors.affiliation: Blood Purification Technologies Inc., Beverly Hills, California, USA.
authors.forename: Carlos
authors.initials: C
authors.lastname: Ezon
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, Washington, USA.|Department of Health Services, School of Public Health, University of Washington, Seattle, Washington, USA.
authors.forename: Larry
authors.initials: L
authors.lastname: Kessler
authors.affiliation: Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, Washington, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Himmelfarb