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Kidney Week

Abstract: PO2633

Health Economic Evaluation of the Theranova 400 Dialyzer Among Hemodialysis Patients in the United States: Results from a Randomized-Controlled Trial

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis


  • Blackowicz, Michael J, Baxter International Inc, Deerfield, Illinois, United States
  • Falzon, Luke, Baxter Healthcare Corp Malta, San Gwann, Malta
  • Xiao, Mengqi, Baxter International Inc, Deerfield, Illinois, United States
  • Bernardo, Angelito A., Baxter Healthcare Corp Malta, San Gwann, Malta
  • Tran, Ha, Baxter International Inc, Deerfield, Illinois, United States

In a 24-week, open-label RCT, expanded hemodialysis (HDx) via the Theranova 400 medium cut-off dialyzer had superior reduction ratios of large middle molecule uremic toxins such as κ and λ free light chains, complement factor D, TNF-α, and β2-microglobulin, compared to a high-flux dialyzer (Elisio-17H) in the US (Weiner et al. 2020). The purpose of this study is to perform a cost-consequence analysis for comparison of healthcare costs between HDx and conventional high-flux hemodialysis (HD).


Hemodialysis patients were randomized to receive treatment with either Theranova 400 or Elisio-17H over 24 weeks in the US. Hospitalization rate and average length of stay were calculated directly from trial data. Frequency of erythropoiesis stimulating agent (ESA) and iron use were calculated at baseline and carried forward over a 1-year time horizon. ESA and iron doses were calculated as the average of median total monthly doses. Unit costs of medication were obtained from the Centers for Medicare and Medicaid Service (CMS) and hospital costs from the Kaiser Family Foundation. Both deterministic (±20%) and probabilistic (95% confidence intervals) sensitivity analyses were conducted to account for variability in model inputs.


There were 86 patients (389 patient-months) in the Theranova group and 85 patients (366 patient-months) in the Elisio group. All-cause hospitalization rate was 43% lower with Theranova compared to Elisio (RR=0.57; p=0.069). Frequency of ESA use was 46.5% in the Theranova group compared to 55.8% in the Elisio group, but doses were similar between the two groups. Both frequency and dose of iron were similar between the two groups. Average annual cost of hospitalization was $3,925 lower with Theranova compared to Elisio. Annual cost of ESAs and iron were similar between the two groups, although the cost of ESAs was $400 lower in the Theranova group. Compared to Elisio, the average annual cost of Theranova was $4,340 lower per patient. Hospitalization rate and length of stay were the main drivers of cost in the model.


This study provides evidence that, in addition to Theranova’s superior removal of large middle molecules, Theranova may also be a cost-saving therapy driven largely by reduction in patient hospitalization events.