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Kidney Week

Abstract: FR-PO488

Efficacy and Safety of Expanded Hemodialysis Enabled by a Medium Cut-Off Membrane: A Randomized Control Trial

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Weiner, Daniel E., Tufts Medical Center, Boston, Massachusetts, United States
  • Falzon, Luke, Baxter Healthcare Corporation, Deerfield, Illinois, United States
  • Beck, Werner, Baxter Healthcare Corporation, Deerfield, Illinois, United States
  • Xiao, Mengqi, Baxter Healthcare Corporation, Deerfield, Illinois, United States
  • Tran, Ha, Baxter Healthcare Corporation, Deerfield, Illinois, United States
  • Bernardo, Angelito A., Baxter Healthcare Corporation, Deerfield, Illinois, United States
Background

End stage kidney disease patients suffer high morbidity and mortality. Evidence suggests that accumulated uremic toxins, including larger middle molecules poorly cleared with conventional hemodialysis (HD), have a significant role in inflammation, cardiovascular disease and immune modulation. Expanded HD with a medium cut off membrane may effectively and safely remove middle molecules compared to conventional HD.

Methods

A 24 week, open-label RCT in thrice weekly in-center HD patients assessed whether a medium cut-off dialyzer (Theranova 400) compared to a high flux dialyzer (Elisio-17H) was superior in reduction ratio (RR) of lambda free light chains (λ FLCs) as a representative larger middle molecule (primary efficacy outcome) and non-inferior in maintaining pre-dialysis serum albumin levels (primary safety outcome). Primary analyses used an ANCOVA model with fixed effects for treatment and site, with multiple imputation for missing values performed using all post-baseline values. Secondary outcomes (shown in the table) used a mixed-effects repeated measures model.

Results

Among 172 patients randomized at 21 sites, mean age was 59 years, 39% were women and 40% African American. Median vintage was 4 years and 45% had diabetes as the cause of ESRD. The λ FLC reduction ratio was significantly higher with the Theranova membrane, while albumin levels were similar between groups (Table). Adverse and serious adverse events also were similar between groups.

Conclusion

The Theranova 400 dialyzer provides superior removal of larger middle molecules as compared to a similar size high flux dialyzer while maintaining serum albumin level without adverse safety signals. Larger studies of longer duration are needed to to assess if better larger middle molecule clearance is associated with improvements in clinical outcomes, including vascular disease, quality of life and mortality.

Primary* and Secondary‡ Outcomes
 Theranova 400Elisio 17HTheranova 400 - Elisio 17H
OutcomesMean (SD)Mean (SD)Mean Estimated Treatment Difference (SE)95% CI or p-value
λ FLC (% RR)*32.2 (12.6)17.5 (12.7)14.810.5, 19.2
Serum Albumin (g/dL)*4.03 (0.28)4.02 (0.39)-0.015-0.098,0.069
Complement Factor D (% RR)‡38.1 (11.2)14.6 (11.3)23.5 (2.0)<0.001
κ FLC (% RR)‡59.3 (13.1)43.9 (14.9)15.4 (2.5)<0.001
IL-6 (% RR)‡-0.9 (46.2)-14.8 (43.6)14.0 (7.9)0.08
TNFα (% RR)‡44.5 (10.2)34.5 (10.7)10.0 (1.8)<0.001
β2-microglobulin (% RR)‡73.6 (10.4)65.4 (9.4)8.2 (1.8)<0.001

RR, reduction ratio

Funding

  • Commercial Support