Quanta™ Announces Enrollment Completion in Home Run Study
Multi-center trial assesses efficacy and safety of the Quanta Dialysis System
BEVERLY, Massachusetts – August 17, 2023 – Quanta Dialysis Technologies® today announced that it has completed enrollment of its Home Run study for at-home hemodialysis. The Home Run study is a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for home hemodialysis. Results are expected to be announced in the second half of 2023.
“People with end-stage kidney disease on hemodialysis are currently limited as to options available. Although frequent home hemodialysis is proven to deliver superior outcomes, for many, in-center dialysis treatment three times a week is the only viable option,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, FASN. “We hope that FDA clearance of an additional home hemodialysis device will contribute to more patients having access to regular care in their home environment. Enrollment completion is the first step forward in a potential new alternative for people with this life-threatening disease.”
About the Home Run Study
The Home Run study is establishing non-inferiority in safety and efficacy when the Quanta Dialysis System is used in the self-care home environment with a care partner compared to a hemodialysis facility. Following enrollment, study participants begin hemodialysis treatments using the system on a prescription of four-hour treatments, three times per week for a minimum of four weeks. During this time, both patients and their caregivers will undergo extensive training and competency sign off on all aspects of safely administering hemodialysis treatment in the home. Upon completion of training and a one-week transition period, participants will perform home treatment four times per week for three-and-one-half hours per treatment for eight weeks.
About End-Stage Kidney Disease (ESKD)
End-stage kidney disease is the final stage of chronic kidney disease, where kidney function has declined enough to the point where the kidneys can longer function on their own. With fully functioning kidneys, waste and excess fluids from the blood are filtered and then excreted in urine. For those with ESKD, the kidneys lose their filtering abilities and dangerous levels of fluid, electrolytes and waste build up in the body. Approximately 800,000 people in the United States are living with ESKD, 71% of which rely on dialysis to manage the disease, while the remaining 29% have a functioning kidney transplant.
About the Quanta Dialysis System
The Quanta Dialysis System is a compact, easy-to-use hemodialysis device FDA-cleared for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. It is also CE-mark approved for use in center or at-home in the UK by adult patients with AV fistula or graft or central venous catheter, and who have an estimated dry weight of greater than 40kg.