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. 2025 Mar 4;36(8):1614-1625.
doi: 10.1681/ASN.0000000655.

Expanded Hemodialysis with Theranova Dialyzer and Residual Kidney Function in Patients Starting Long-Term Hemodialysis: A Randomized Controlled Trial

Jeong-Hoon Lim  1 , Yu Jin Seo  2 , Yena Jeon  3 , You Hyun Jeon  1 , Hee-Yeon Jung  1 , Ji-Young Choi  1 , Sun-Hee Park  1 , Chan-Duck Kim  1 , Seok Hui Kang  4 , Jung-Hwa Ryu  5 , Duk-Hee Kang  5 , Jang-Hee Cho  1 , Yong-Lim Kim  1
Affiliations

Expanded Hemodialysis with Theranova Dialyzer and Residual Kidney Function in Patients Starting Long-Term Hemodialysis: A Randomized Controlled Trial

Jeong-Hoon Lim et al. J Am Soc Nephrol. .

Abstract

Key Points:

  1. This randomized controlled trial evaluated the effect of expanded hemodialysis on preserving residual kidney function in patients starting treatment with long-term hemodialysis.

  2. The expanded hemodialysis group with Theranova dialyzer showed smaller decrease in GFR than the high-flux group over 12 months.

  3. The Theranova group had a larger reduction in middle molecules and inflammatory cytokines and smaller increases in kidney injury markers.

Background: Expanded hemodialysis using a medium cutoff dialyzer improves the clearance of middle-molecular toxins compared with conventional hemodialysis. This study evaluated the effect of expanded hemodialysis on preserving residual kidney function in patients starting treatment with long-term hemodialysis.

Methods: Patients who initiated long-term hemodialysis were randomized to receive dialysis with either a Theranova 400 (Baxter) or a high-flux dialyzer with a similar surface area over 12 months. The primary outcome was a change in GFR over 12 months, as determined by the mean of urea and creatinine clearance. The secondary outcome was a change in 24-hour urine volume, middle molecules, and kidney injury markers.

Results: A total of 80 patients on hemodialysis (mean age [SD]: 63 [12] years; male: 52 [65%]) underwent randomization. Over 12 months, the Theranova group demonstrated a significantly smaller decrease in GFR than the high-flux group (least squares mean difference of change [95% confidence interval], −1.4 [−2.4 to −0.5] ml/min per 1.73 m2). Theranova maintained greater 24-hour urine volume until 9 months, not at 12 months, compared with the high-flux dialyzer. The reduction ratio for κ/λ free light chains, TNF-α, and growth differentiation factor-15 was higher in the Theranova group than in the high-flux group. The increase in the kidney injury marker, IGF-binding protein 7, was attenuated in the Theranova group. Hospitalization rate and mortality did not differ between the two groups.

Conclusions: This trial suggests that expanded hemodialysis using the Theranova dialyzer slowed decline in residual kidney function compared with a high-flux dialyzer in patients starting treatment with long-term hemodialysis.

Clinical Trial registry name and registration number:: Theranova versus High-flux Dialyzer on Preservation of Residual Renal Function, NCT04211571.

Keywords: ESKD; dialysis; hemodialysis.

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Conflict of interest statement

Disclosure forms, as provided by each author, are available with the online version of the article at http://links.lww.com/JSN/F107.

References

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