HDx Therapy

Expanded Hemodialysis may make a World of Difference for patients, clinicians & healthcare systems

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 (LMMs)² which have been linked to inflammation, cardiovascular disease, and other co-morbidities in dialysis patients.^3,4

Evidence on Performance

Expanded Hemodialysis enabled by the Theranova dialyzer* is a dialysis treatment where diffusion and convection are conveniently combined along the MCO membrane, a hollow fiber dialyzer equipped with a High Retention Onset (HRO) membrane¹ – defined as medium cut-off.
HDx therapy is performed with no special requirement of a particular hardware, preparation of replacement fluid, or additional nursing skill, compared to the necessary ones required to perform conventional hemodialysis (HD) in standard mode.³

Consensus of Experts

Expanded Hemodialysis describes a treatment using a filter with a high molecular weight retention onset and a molecular weight cut-off similar to or 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 cutoff just below albumin.^5,6

Standardisation of Nomenclature

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Definition of Extracorporeal Techniques

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Classification of Uremic Toxins and Their Role in Kidney Failure

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Watch patient testimonial

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

Patient-Reported Outcomes

HDx therapy enabled by the Theranova dialyzer may improve patient-reported outcomes.^7,8,9
Patient-reported symptom burden has a significant impact on patient QoL.¹⁰

Evidence on PRO

42% of patients suffer from moderate to severe pruritus¹¹ HDx therapy may significantly lower uremic pruritus, a predictor of poor sleep, in HD patients.¹²
20% of patients with end-stage-renal-disease (ESRD) will have restless leg syndrome (RLS)^13,14 HDx therapy enabled by the Theranova dialyzer may reduce the ocurrence of RLS, common in HD patients.^4,7
68% of patients report >2 hours to recover^8,1
HDx therapy enabled by the Theranova dialyzer may significantly reduce recovery time, a patient reported outcome also associated with increased risks of hospitalizations and mortality.^8,15-16

Economic Outcomes

HDx therapy enabled by the Theranova dialyzer can help free resources and relieve the strain on healthcare systems^17-19

HDx therapy enabled by the Theranova dialyzer may reduce hospitalization rates^3,19
HDx therapy enabled by the Theranova dialyzer has been associated with decreases in medication usage^19-21
HDx therapy enabled by the Theranova dialyzer may reduce pressures on healthcare systems and total cost of care^3,19-23

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.¹⁹

Research has shown patients receiving HDx therapy may have a decreased Erythropoietin Resistance Index (ERI). Also these patients may need a lower ESA dose over time without concomitant reduction in hemoglobin level, when compared with High-Flux HD and HDF patients.^12,18,20,23
A retrospective, observational study found that, compared to HF HD, nonfatal cardiovascular events were 35% lower with HDx therapy.¹⁷
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.^17-20,22-23

Expertise in membrane manufacturing: MCO membrane to perform HDx therapy

Baxter’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.^1,24

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.^1,3,25
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.^1,3,25
Adsorptive properties of MCO membrane make it a safe and effective barrier against potential dialysis fluid contaminants despite the higher permeability.^2,3,26

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

Supporting Material

Deep dive into the world of Expanded Hemodialysis enabled by the Theranova* dialyzer through our curated selection of downloadable material.

Compendium of Studies

Explore how the evidence on patient-reported, clinical and economic outcomes continues to grow within HDx therapy.

Explore The Compendium of Studies

Brochure

Discover how HDx therapy enabled by the Theranova* dialyzer may make a world of difference for patients, clinicians, and healthcare systems.

Download HDx Therapy Brochure

Data sheet

Detailed profiles of Theranova* dialyzers.

View Theranova dialyzer Specification Sheets

Learn more about HDx therapy

HDx

Theranova: a Game-Changer for Patients and Healthcare Providers Alike

Remote Patient Management technology enhances the experience of Automated Peritoneal Dialysis

HDx

Patient Testimonials

Important Safety Information

Theranova dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

*Do not use Theranova dialyzers in hemodiafiltration (HDF) or hemofiltration (HF) mode.

For safe and proper use of this device, please refer to Instructions for Use.

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References

Boschetti-de-Fierro A et al. MCO membranes: enhanced selectivity in high-flux class. Nature/Sci Rep. 2015; 5:18448. doi:10.1038/srep18448.
Rosner M et al. Classification of Uremic Toxins and Their Role in Kidney Failure. Clin J Am Soc Nephrol. 2021;16(12):1918-1928.
Ronco C. The Rise of Expanded Hemodialysis. Blood Purif. 2017:44:I-VIII.
Hutchison CA, Wolley M. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol. 2017; 191:142-52.
Meijers B et al. Extracorporeal Techniques in End-Stage Kidney Disease. Blood Purif. 2023; 929–944.
Maduell F, Broseta JJ. Hemodiafiltration (HDF) versus expanded hemodialysis (HDx). Semin Dial. 2022;375-460.
Alarcon JC et al. Impact of Medium Cut-Off Dialyzers on Patient-Reported Outcomes (PROs): COREXH Registry. Blood Purif. In Press.
Bolton S et al. Clinical Assessment of Dialysis Recovery Time and Symptom Burden: Impact of Switching Hemodialysis Therapy Mode. Patient Relat Outcome Meas. 2021;12:315-321.
Lim JH et al. Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients. Nature/Sci Rep. 2020; 10:7780.
Zhang JC et al. Could symptom burden predict subsequent healthcare use in patients with end stage kidney disease on hemodialysis care? A prospective, preliminary study. Ren Fail. 2020;42(1):294-301.
Pisoni RL et al. Pruritus in haemodialysis patients: International results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2006;21(12):3495-3505.
Lim JH 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.
Lin XW et al. Restless legs syndrome in end stage renal disease patients undergoing hemodialysis. BMC Neurol. 2019.19:47.
Freire de Menezes A et al. Int J Nephrol. 2018;25;2018:1414568.
Rayner HC et al. Recovery time, quality of life, and mortality in hemodialysis patients: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 2014;64:86–94
Anwar N et al. HDx: is it a better way to dialyse? Nephrol Dial Transplant. 2020;35(3):1109.
Molano-Trivino A et al. Effectiveness of medium cut-off vs high flux dialyzers: a propensity score matching cohort study. In Nephrol Dial Transport. 2021;36:486-U948.
Sanabria RM et al. Expanded Hemodialysis and Its Effects on Hospitalizations and Medication Usage: A Cohort Study. Nephron. 2021;145(2):179-187.
Blackowicz MJ 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. Hemodialysis International. 2022;449–455.
Ariza JG et al. An initial evaluation of expanded hemodialysis on hospitalizations, drug utilization, costs, and patient utility in Colombia. Ther Apher Dial. 2021;1-7. https://doi.org/10.1111/1744-9987.13620
Cantaluppi V et al. Removal of large-middle molecules on expanded hemodialysis (HDx): a multicentric observational study of 6 months follow-up. ASN 2018 Kidney Week Abstract TH-PO357.
Cozzolino M et al. Effects of a medium cut-off (THERANOVA®) dialyser on haemodialysis patients: a prospective, cross-over study. Clin. Kidney J. 2021;14(1):382-389.
Hadad-Arrascue F et al. Expanded hemodialysis as effective alternative to on-line hemodiafiltration: A randomized mid-term clinical trial. Ther Apher Dial. 2022;26(1):37-44.
Ronco C, Clark WR. Haemodialysis membranes. Nat Rev Nephrol. 2018;14(6):394-410.
Zweigart C et al. Medium cut-off membranes – closer to the natural kidney removal function. Int J Artif Organs. 2017; 40(7):328-334.
Boschetti-de-Fierro A et al. Membrane Innovation in Dialysis. Contrib Nephrol. 2017;191:100-114.

Therapies

Products

Data & Insights

HDx Therapy

One Change can Transform HD Treatment

Consensus of Experts

Watch patient testimonial

Patient-Reported Outcomes

Economic Outcomes

Expertise in membrane manufacturing: MCO membrane to perform HDx therapy

Going Beyond Urea and Beta-2 Microglobulin

Supporting Material

Compendium of Studies

Brochure

Data sheet

Learn more about HDx therapy

Theranova: a Game-Changer for Patients and Healthcare Providers Alike

Remote Patient Management technology enhances the experience of Automated Peritoneal Dialysis

Patient Testimonials

Are you interested in learning more?

Important Safety Information