The Next Frontier of Dialysis Care
We’re building the future of dialysis with a device-agnostic, research-driven approach to middle molecule clearance, exploring the clinical and quality of life benefits of both Hemodiafiltration (HDF) and Expanded hemodialysis (HD)
Improved Clinical Outcomes
International evidence links enhanced middle molecule clearance to improved patient outcomes.1,2,3
Enhanced Quality of Life
Patients report improvements in areas like sleep, post-treatment recovery, ​​cognitive function and itching or restless legs. 4, 5, 6
​​​Multiple Promising Pathways
Both Expanded HD and HDF have been shown in multiple studies to be safe and effective treatments for ESKD. 1, 7, 8, 9
Large Molecular Size
Protein Binding
Redefining Quality Care: The Clinical Impact of Middle Molecules
Middle molecules have been correlated with increased inflammation, cardiovascular disease, and other complications for patients with kidney failure. 10, 11
Today, high-flux hemodialysis offers modest clearance of middle molecules due to large molecular size and protein binding. Advanced therapies—like Expanded Hemodialysis and Hemodiafiltration—that better remove these toxins may improve clinical outcomes and quality of life.
Pursuing Multiple Pathways to Better Outcomes
Expanded Hemodialysis (Expanded HD)
Expanded HD uses innovative medium cut-off dialyzers in existing dialysis machines to help improve clearance of middle molecules. Results from the MOTheR8 trial — one of the most rigorous head-to-head studies of advanced therapies — and CONCORDIA9 studies confirm that across both clinical trial and real-world settings, Expanded HD and HDF deliver comparable outcomes.
High-Volume Hemodiafiltration (HDF)
We are deploying an initial pilot of 100 new, FDA-approved HDF machines. This pilot will give us critical insight into U.S. clinical and operational outcomes amid the various changes HDF requires of patients, nephrologists and clinical staff. This will help contribute to the foundational, real-world evidence needed to validate this therapy for U.S. patients.
New Initiatives Explore Middle Molecule Clearance
New data proves expanded hemodialysis effectively improves middle molecule clearance
These two initiatives evaluate how advanced dialysis treatments impact survival and quality of life.
Two Approaches, Greater Potential Access
View a brief explainer on two promising pathways to enhance middle molecule clearance
Latest Industry News on Dialysis Care
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As therapies emerge in the U.S. to address middle-molecule clearance, stay informed on how ÑÇÖÞÎÞÂë is unlocking next-generation dialysis to provide physicians tools and evidence for improved patient outcomes.
Dr. Giullian discusses how new evidence supports individualized physician choice and expanded patient access….
We explore how new evidence from the MOTheR trial supports an improved care experience and expanded options for our patients….
FAQ
Middle molecules are a class of larger uremic toxins (waste particles) with a molecular weight typically ranging from 0.5 to 60 kDa. Examples of middle molecules include β2-microglobulin, myoglobin and free light chains.
In patients with kidney failure, middle molecules can build up in the blood over time. This accumulation is correlated with higher systemic inflammation, a weakened immune response, and an increased risk of cardiovascular disease and all-cause mortality.
The buildup of these toxins is also associated with disruptive physical symptoms that affect how patients feel. These symptoms include itching, restless legs, fatigue, decreased appetite, poor sleep, and longer recovery times after dialysis treatments.
Because both technologies are just emerging in the U.S., equipment supplies and access are limited. With the goal of bringing enhanced middle molecule clearance to patients quickly, we are taking a two-fold approach: 1) Continuing to evaluate and conduct critical research on both technologies, while 2) preparing our operations to deliver advanced middle molecule clearance as quickly as possible.
A growing body of international clinical evidence reinforces that both online Hemodiafiltration (HDF) and Expanded HD (using specialized high-performance dialyzers) offer similar, improved patient outcomes.
ÑÇÖÞÎÞÂë is committed to a method-agnostic approach, with rigorous investigation of all options in pursuit of better patient outcomes. This commitment will help expand the choices available to nephrologists, so they can best personalize treatment based on the unique needs of each patient.
Expanded Hemodialysis is a kidney replacement therapy that uses specialized high-performance dialyzers, often referred to as medium cut-off or super high-flux dialyzers. These dialyzers work in standard dialysis machines and feature highly permeable membranes with a steep, tight pore size distribution. This allows larger middle molecules to easily pass through and be cleared from the blood, while selectively retaining essential proteins like albumin.
Hemodiafiltration (HDF) is an advanced dialysis modality that has been used internationally and is currently emerging in U.S. dialysis centers through specialized machines. HDF combines standard diffusion with high-volume convection. It removes a large volume of fluid during treatment (often >23 liters) to effectively ​​clear large middle molecules from the blood. Because so much fluid is removed during HDF, the machine replaces it simultaneously with an ultra-clean, purified substitution fluid.Â
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[1] Blankestijn PJ, Vernooij RWM, Hockham C, et al. Effect of Hemodiafiltration or Hemodialysis on Mortality in Kidney Failure. N Engl J Med. 2023;389(8):700-709. doi:10.1056/NEJMoa2304820
[2] Abe, M., Masakane, I., Wada, A. et al. High-performance dialyzers and mortality in maintenance hemodialysis patients. Sci Rep 11, 12272 (2021).
[3] Castillo JC, Vesga J, Rivera A, et al. Survival Differences in Patients with High-Flux Hemodialysis versus Expanded Hemodialysis: A Cohort Study. Blood Purif. 2025;54(12):772-781. doi:10.1159/000548158
[4] Rose M, Fischer FH, Liegl G, et al. The CONVINCE randomized trial found positive effects on quality of life for patients with chronic kidney disease treated with hemodiafiltration. Kidney Int. 2024;106(5):961-971. doi:10.1016/j.kint.2024.07.014
[5] 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 10, 7780 (2020). https://doi.org/10.1038/s41598-020-64622-z
[6] Penny JD, Gozdzik D, Tamasi T, et al. Impact of Expanded Hemodialysis on Subjective Experience Using Dynamic Patient-Reported Outcome Measurement Tool. Kidney Med. 2025;7(12):101134. Published 2025 Oct 10. doi:10.1016/j.xkme.2025.101134
[7] Castillo JC, Doria C, Cely J, et al. Efficacy in the reduction ratios of middle molecules with the use of medium cut-off dialyzers and reduced dialysate flows: a cohort study. Front Med (Lausanne). 2025;12:1663750. Published 2025 Oct 9. doi:10.3389/fmed.2025.1663750
[8] De Sequera Ortiz P, Pérez GarcÃa R, MartÃnez-Vaquera S, et al. MOTheR HDx Study: A MOPR Study to Explore Morbidity and Mortality in Patients Dialyzed with Theranova HDx Compared with OL-HDF. Abstract presented at: ERA Congress; 2026.
[9] Pecoits-Filho R, Ferraro PM, et al. The CONCORDIA Study: All-Cause Mortality with HDx with Theranova Compared with Hemodiafiltration Using DOPPS as an External Real-World Comparator. Abstract presented at: ERA Congress; 2026.
[10]Wolley MJ, Hutchison CA. Large Uremic Toxins: An Unsolved Problem in End-Stage Kidney Disease. Nephrology, Dialysis, Transplantation. 2018;33(suppl_3):iii6-iii11.
[11]Fatigue in Patients Receiving Maintenance Hemodialysis: A Review. Bossola, Maurizio et al. American Journal of Kidney Diseases, Volume 82, Issue 4, 464 – 480