Wearable Artificial Kidney Has Successful Human Trial
In a 24-hour exploratory trial, all 7 patients who wore the device remained hemodynamically stable over the study period.
SAN DIEGO—Researchers at Kidney Week reported promising findings from an exploratory study of a wearable artificial kidney (WAK).
The device is a miniaturized hemodialysis machine based on dialysate-regenerating sorbent technology.
Victor Gura, MD, of Cedars-Sinai Medical Center in Los Angeles and the David Geffen School of Medicine at the University of California Los Angeles, and colleagues assessed the device over a 24-hour trial that enrolled 7 patients with end-stage renal disease. According to the investigators, all patients remained hemodynamically stable and experienced no serious adverse events over the 24-hour study period. Fluid removal was consistent with prescribed ultrafiltration, Dr. Gura's group stated in a poster presentation.
Five patients completed the planned 24 hours of study treatment; 2 completed 4 hours and 10 hours. Of the 7 patients, 6 ambulated while wearing the WAK. Patients ate a normal diet during the study, with ad lib ingestion of water and without restricting salt, phosphate, or potassium-rich foods, Dr. Gura and his colleagues noted.
“All patients reported that they would switch to the WAK if the device were commercially available,” the authors wrote.
The trial was supported through the FDA's Center for Devices and Radiological Health's Innovation Pathway 2.0, the researchers stated.