A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of the Quanta Dialysis System for Home Hemodialysis

Wael Hussein; Prashanth Ashok Kumar; Naveen K. Atray; Doreen W. Bett; Chak K. Chan; Matthew J. Diamond; Gopa Green; Nupur Gupta; Bethany E. Karl; Andrea Kattah; Justin Merszei; Melvin Seek; Suzanne Watnick; Eric D. Weinhandl; Reid Whitlock; Lisa Bismarck; Kelley L. Gorbe; Paul V.J. Komenda

doi:10.1016/j.xkme.2026.101317

March 1, 2026Kidney MedicineOpen Access

A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of the Quanta Dialysis System for Home Hemodialysis

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Key result

Quanta Dialysis System proves non-inferior to traditional facility-based hemodialysis for efficacy and safety.

Why the study?

Does the Quanta Dialysis System for home hemodialysis provide non-inferior efficacy and safety compared to facility-based hemodialysis in adults with end-stage kidney failure?

Key Points

This research aims to assess both the efficacy and safety of the Quanta Dialysis System used for home hemodialysis.
Conducted as a multi-center, open-label study.
Participants included 29 evaluable individuals at the first clinic visit.
Follow-up assessments were made during in-home visits, with 27 participants providing complete data.
Demonstrated non-inferiority of the Quanta Dialysis System compared to current standards.
Statistical analysis involved one-sided p-values and repeated measures ANOVA.

Structured PICO

Does the Quanta Dialysis System for home hemodialysis provide non-inferior efficacy and safety compared to facility-based hemodialysis in adults with end-stage kidney failure?

P

Population

34 adults with end-stage kidney failure (ESKF) currently undergoing dialysis for ≥90 days, mean age 53.9, 44.1% female, US-based. Key inclusion: cleared by physician, had a care partner, and suitable internet, electricity, and water supply at home.

I

Intervention

Quanta Dialysis System for home hemodialysis (HHD) 4x/week, 3.5 hours each session, for 8 weeks without direct supervision (In-Home Phase).

C

Comparator

Facility-based hemodialysis by clinical staff 3x/week, 4 hours each session, for 4 to 8 weeks (In-Clinic Phase).

O

Outcome

Mean standardized weekly Kt/V ≥2.1 calculated using the Leypoldt chain (efficacy) and a composite outcome of device- or procedure-related adverse events (safety).surrogate

Self-care home hemodialysis using the Quanta Dialysis System is safe and provides non-inferior dialysis clearance compared to facility-based hemodialysis.

Limitations

nature of the intervention precluded a randomized cross-over design

Implication

Supports self-care home HD with Quanta in ESKD; extends evidence for accessible alternatives to facility-based care.

Abstract

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Discussion

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Cite This Study

Hussein et al. (2026) studied this question. The Quanta Dialysis System demonstrated non-inferiority in efficacy and safety for home hemodialysis compared to traditional methods.

synapsesocial.com/papers/69b3ab2902a1e69014ccbdbd https://doi.org/10.1016/j.xkme.2026.101317

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A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of the Quanta Dialysis System for Home Hemodialysis

Key Points

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of the Quanta Dialysis System for Home Hemodialysis

Key Points

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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