Patient receiving treatment

HDx therapy enabled by Theranova dialyzer

One change can transform HD treatment

HDx therapy enabled by Theranova dialyzer* brings us one step closer to the natural kidney.1 It helps with efficient removal of large-middle molecules,2 which have been linked to inflammation, cardiovascular disease and other comorbidities in dialysis patients.3,4

HDx therapy delivers expanded hemodialysis therapy, which is a dialysis treatment that combines diffusion and convection inside a hollow fiber dialyzer equipped with MCO membrane, the medium cut-off membrane. This is possible with no special requirement of a particular hardware, preparation of replacement fluid, or additional nursing skill: HDx therapy delivery is similar to conventional hemodialysis (HD).3

Evidence on performance

Consensus of experts

Expanded Hemodialysis describes a treatment using a filter with a high molecular weight retention onset and a molecular weight cut-off exceeding high-flux HD.5,6 

Due to changes in filter geometry with a smaller inner diameter to promote internal filtration and back filtration, the volume of convective transport exceeds that of high-flux HD. This is combined with diffusive transport, without the use of replacement fluids.5,6 

This allows augmented clearances of molecules in a very broad spectrum of molecular weight from small water-soluble molecules to middle molecules with a molecular weight/size cut-off just below albumin.5,6

Standardization of nomenclature

Standardization of nomenclature for the mechanisms and materials utilized for extracorporeal blood purification

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Definition of extracorporeal techniques

Extracorporeal techniques in kidney failure

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Classification of uremic toxins and their role in kidney failure

Advances in our understanding of uremic retention solutes, and improvements in hemodialysis membranes and other techniques designed to remove uremic retention solutes, offer opportunities to readdress the definition and classification of uremic toxins.

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Watch Robert Wahby share his story about undergoing HDx therapy and understand the science behind it with the renowned Dr. McIntyre.

Theranova dialyzer: patients speak about their experience

Andre, patient on HDx Therapy

"when I told (my doctor) about (my restless leg syndrome), she had the idea to switch me over to Theranova dialyzer. And after that, I got better. That was amazing. And I could finally sleep again. Sleep peacefully. All the symptoms have completely changed with the new dialyzer. It gave me a new lease of life."

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Shatila, caregiver for mother on HDx therapy

"When she started with Theranova dialyzer, after a few weeks, like within 2 months, I can see that her itchiness has reduced by 90%, and after like four months, there is no itchiness, ... she doesn't scratch. ... That is like a result that you can see."

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Dennis, patient on HDx therapy

"I feel, in myself, Theranova dialyzer definitely made an impact on my family life, home life and all parts of my life. I can do things that I couldn't do … I go take my kids out to the park."

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Robert, patient on HDx therapy

"... couple days after using it, ... I started to feel better ... I was eating a little better, and my sleep wasn't great, but it was way better, much improved. So, I thought, boy, this is ridiculous. Then I started thinking - wait a minute - this is not imaginary ... obviously there is a difference in the dialyzer."

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Patient-reported outcomes

HDx therapy enabled by Theranova dialyzer is associated with a significant reduction in symptom burden vs high-flux patient experience:

  • Up to 73% of patients reported a reduction in the severity of pruritus at 3 months.7
  • A 55% decrease in the proportion of patients meeting RLS diagnostic criteria after 12 months.7
  • Up to 2.5 hours reduction in patient-reported post-dialysis recovery time was seen in patients on HDx therapy over a 6-month follow-up period.8
Evidence on patient-reported outcomes
A nurse attentively converses with an elderly woman
Evidence on patient-reported outcomes

Economic outcomes

HDx therapy enabled by Theranova dialyzer has been associated with reduction of the total cost of care, primarily driven by reductions in the healthcare resource utilization related to cardiovascular events (35% reduction),* infections, medication usage and all-cause hospitalizations (45% reductions),† when compared with HD therapy. 9-13

  • Patients treated with Theranova dialyzer have up to 45% lower rate of all-cause hospitalizations compared to patients treated with high-flux HD.†13
  • HDx therapy enabled by Theranova dialyzer, has been associated with a significant reduction of 37.2% in ESA dosage at 12 weeks in patients that were previously treated with high-flux HD therapy.‡12
  • In a retrospective observational study, following 1098 patients over a 2-year follow-up period, HDx Therapy enabled by Theranova dialyzer, was associated with a 35% reduction in non-fatal cardiovascular events compared to high-flux HD.*9

*Retrospective, observational study (n=1,098).

†Prospective, randomized, controlled, open-label, parallel study of US HD patients; HDx (n=86) and high-flux HD (n=85).

‡Prospective, randomized, single-center, controlled trial (n=49).

Evidence on economics
A healthcare professional holds a Theranova dialyzer by a AK 98 machine
Evidence on economics

A randomized controlled trial of 171 prevalent HD patients showed a 45% lower all-cause hospitalization rate over 12 months with HDx therapy compared to the control high-flux HD arm.13

  • Research has shown patients receiving HDx therapy may have a decreased erythropoietin resistance index (ERI). Also these patients may need a lower erythropoietin stimulating agents (ESA) dose over time without concomitant reduction in hemoglobin level, when compared with high-flux HD and Hemodiafiltration (HDF) patients.12,14,15,17
  • A retrospective, observational study found that, compared to (HF HD), nonfatal cardiovascular events were 35% lower with HDx therapy.10
  • HDx therapy may offer healthcare systems the opportunity to reduce the total cost of care, driven by potential reduction of cardiovascular events, infections, medication usage, hospitalizations, hospitalization rate and length of stay.10,11,15-17

Expertise in membrane manufacturing: MCO membrane to perform HDx therapy

Vantive’s membrane-formation technologies have enabled precise control of pore-size distribution, which results in a narrow pore-size distribution with a significant number of pores that are large enough for middle molecules to penetrate but small enough for albumin to not pass through.1,18

Smiling man getting treatment

Four principles combine in a single dialyzer device design:

  • MCO membrane has increased nominal pore size that provides significantly higher permeability for large-middle molecules vs high-flux membranes used for conventional HD and HDF.1,3,19
  • MCO membrane unique asymmetric 3-layer structure controls the distribution of pore sizes for a stable solutes separation profile.1
  • MCO membrane’s reduced inner diameter increases the convective transport along the membrane, within the same hollow fiber dialyzer that performs diffusion.1,3,19
  • Adsorptive properties of MCO membrane make it a safe and effective barrier against potential dialysis fluid contaminants despite the higher permeability.2,3,20

Going beyond urea and beta-2 microglobulin

The clinical symptoms and conditions associated with uremic toxins differ according to their molecular weight, with the large-middle molecules being linked to several clinical effects.2

Evidence on clinical effectiveness

Are you interested in learning more?

Contact Vantive to learn more about HDx therapy enabled by Theranova dialyzer.

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Important Safety Information

Please click here for important safety information.

Vantive, HDx, MCO and Theranova are trademarks of Vantive Health LLC or its affiliates.

 

References

  1. Boschetti-de-Fierro A, Voigt M, Storr M, Krause B. MCO membranes: enhanced selectivity in high-flux class. Nature/Sci Rep. 2015; 5:18448. 

  2. Rosner M, Reis T, Husain-Syed F, et al. Classification of uremic toxins and their role in kidney failure. Clin J Am Soc Nephrol. 2021;16(12):1918-1928.

  3. Ronco C. The rise of expanded hemodialysis. Blood Purif. 2017;44:I-VIII.

  4. Hutchinson CA, Wolley M. The rationale for expanded hemodialysis therapy (HDx). Contrib Nephrol. 2017;191:142-152.

  5. Meijers B, Vega A, Juillard L, et al. Extracorporeal techniques in end-stage kidney disease. Blood Purif. 2023;929–944.

  6. Maduell F, Broseta JJ. Hemodiafiltration (HDF) versus expanded hemodialysis (HDx). Semin Dial. 2022;375-460.

  7. Alarcon JC, Bunch A, Ardila F, et al. Impact of medium cut-off dialyzers on patient-reported outcomes: COREXH registry. Blood Purif. 2021;50(1):110-118. 

  8. Bolton S, Gair R, Nilsson LG, Matthews M, Stewart L, McCullagh N. Clinical assessment of dialysis recovery time and symptom burden: impact of switching hemodialysis therapy mode. Patient Relat Outcome Meas. 2021;12:315-321.

  9. Molano AP, Hutchison CA, Sanchez R, et al. Medium cutoff versus high-flux hemodialysis membranes and clinical outcomes: a cohort study using inverse probability treatment weighting. Kidney Med. 2022;4(4):100431.

  10. Molano-Triviño A, Sanabria M, Vesga J, Buitrago G, Sánchez R, Rivera A. Effectiveness of medium cut-off vs high flux dialyzers: a propensity score matching cohort study. Nephrol Dial Transplant. 2021;36(suppl 1):486.

  11. Ariza JG, Walton SM, Suarez AM, Sanabria M, Vesga JI. An initial evaluation of expanded hemodialysis on hospitalizations, drug utilization, costs, and patient utility in Colombia. Ther Apher Dial. 2021;25(5):621-627.

  12. Lim JH, Jeon Y, Yook JM, et al. Medium cut-off dialyzer improves erythropoiesis stimulating agent resistance in a hepcidin-independent manner in maintenance hemodialysis patients: results from a randomized controlled trial. Sci Rep. 2020;10(1):16062.

  13. Blackowicz MJ, Falzon L, Beck W, Tran H, Weiner DE et al. Economic evaluation of expanded hemodialysis with the Theranova 400 dialyzer: A post hoc evaluation of a randomized clinical trial in the United States.Hemodial Int. 2022;26(3):449-455.

  14. Lim JH, Park Y, Yook JM, et al. Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients. Sci Rep. 2020;10(1):1-11. 

  15. Sanabria RM, Hutchison CA, Vesga JI, et al. Expanded hemodialysis and its effects on hospitalizations and medication usage: a cohort study. Nephron. 2021;145(2):179-187.

  16. Cozzolino M, Magagnoli L, Ciceri P, Conte F, Galassi A. Effects of a medium cut-off (THERANOVA®) dialyser on haemodialysis patients: a prospective, cross-over study. Clin. Kidney J. 2021;14(1):382-389.

  17. Hadad-Arrascue F, Nilsson LG, Rivera AS, Bernardo AA, Cabezuelo Romero JB. Expanded hemodialysis as effective alternative to on-line hemodiafiltration: A randomized mid-term clinical trial. Ther Apher Dial. 2022;26(1):37-44.

  18. Ronco C, Clark WR. Haemodialysis membranes. Nat Rev Nephrol. 2018;14(6):394-410.

  19. Zweigart C, Boschetti-de-Fierro A, Hulko M, et al. Medium cut-off membranes – closer to the natural kidney removal function. Int J Artif Organs. 2017;40(7):328-334.

  20. Boschetti-de-Fierro A, Beck W, Hildwein H, Krause B, Storr M, Zweigart C. Membrane innovation in dialysis. Contrib Nephrol. 2017;191:100-114.