SAN DIEGO – Patients undergoing maintenance hemodialysis who wore an artificial kidney for 24 hours achieved electrolyte, solute, and volume homeostasis, results from a small exploratory trial demonstrated.
“Mortality in dialysis patients is unacceptable high and the cost is enormous,” device inventor Dr. Victor Gura said during a press briefing at the annual meeting of the American Society of Nephrology. “They have a significant amount of heart disease, strokes and infections, and yet it’s a demographic issue with more than 500,000 patients in the U.S. with end-stage renal disease.”
Dr. Victor Gura
In a trial supported through the FDA’s Center for Devices and Radiological Health, the investigators conducted a human trial of a wearable artificial kidney, a miniaturized, wearable hemodialysis machine based on dialysate-regenerating sorbent technology that is being developed by Blood Purification Technologies. The objective was to determine the safety and efficacy of the device in achieving electrolyte, solute, and volume homeostasis over a 24-hour period in seven patients.
Dr. Gura, a nephrologist at Cedars-Sinai Medical Center and the David Geffen School of Medicine at the University of California, Los Angeles, reported that all patients remained hemodynamically stable, and there were no serious adverse events over the study period. Fluid removal was consistent with prescribed ultrafiltration. Mean BUN, creatinine, and phosphorus clearances during the first hour of treatment were 21, 20, and 22 mL/min, respectively. Treatment was stopped in one patient due to clotting after four hours. Treatment was stopped in a second patient due to discoloration of dialysate observed after 10 hours. The trial was halted after the seventh patient was enrolled due to device-related problems, including carbon dioxide bubbles in the dialysis circuit, tubing kinks, and variable blood/dialysate flow.
Six out of seven patients ambulated while receiving treatment, and all were able to eat a normal diet with ad lib ingestion of water, without restriction on salt, phosphate, or potassium-rich foods. In semi-structured interviews, all patients reported that they would switch to the device if it were commercially available.
In an abstract describing the study, the researchers characterized the findings “as proof-of-concept of the wearable artificial kidney as an important novel alternative dialysis technology that has the potential to enhance autonomy and improve health-related quality of life for patients with end-stage renal disease.”
The study was supported by an unrestricted grant from the Wearable Artificial Kidney Foundation and by Blood Purification Technologies Inc. One of the study investigators, Dr. Matthew B. Rivara, is supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Gura reported having no financial disclosures.