Clinical trial for Quanta machine shows positive outcomes for patients treated at home
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Key takeaways:
- In the clinical trial, patients moved from in-center dialysis on the Quanta Dialysis System to treatment at home four times a week.
- The trial involved 12 dialysis centers in the United States.
PHILADELPHIA — In a clinical trial, patients placed on home hemodialysis four times a week showed improved outcomes over in-center treatment using the Quanta Dialysis System, according to data presented here at ASN Kidney Week.
The trial for the Quanta Dialysis System (Quanta Dialysis Technologies Ltd), approved by the FDA for acute dialysis but awaiting approval for home use, was conducted from November 2021 to October 2023 at 12 dialysis centers to determine efficacy and safety of the machine for home hemodialysis.
In a poster, Paul Komenda, MD, chief medical officer of Quanta Dialysis Technologies Ltd., and colleagues wrote the aim of the study was to “determine noninferiority of efficacy and safety of the Quanta Dialysis System in self-care HHD vs. in-center [hemodialysis] HD.”
Centers that were part of the trial included Satellite Healthcare, DaVita Kidney Care, Indiana University School of Medicine, the University of San Diego School of Medicine, the Mayo Clinic and the Northwest Kidney Centers.
The trial included adults with kidney failure currently undergoing dialysis for 90 days or more. “Participants received [hemodialysis] HD at their respective HHD training centers for 4 to 8 weeks. While dialyzing, participants and caregivers trained to use the device at home,” the authors wrote. “Once deemed competent by a nephrology care team, participants performed supervised HHD during a transition week, then performed HHD with a care partner for 8 weeks.”
The primary outcome to determine efficacy was dialysis adequacy, which was measured by mean standardized weekly Kt/V, according to the poster.
Thirty-two patients were enrolled in the study; the mean age was 55.5 years; 43.5% of the patients were women and 17 (73.9%) had a fistula or a graft for dialysis access, according to the poster. Four patients had previously been dialyzed with an HHD device.
“Performing self-care HHD with a care partner with the Quanta Dialysis System provided well above the weekly standard Kt/V required for dialysis adequacy at [three times per] week in facility (2.4) and [four times per week] at home (3) in a population exceeding a mean weight of 210 [pounds],” according to the poster.
Reference:
Komenda P, et al. TH-PO308. Presented at: ASN Kidney Week; Nov. 1-5, 2023; Philadelphia.
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