Vantive Highlights Late-Breaking High Clinical Impact Data at ERA Indicating HDx Therapy is a Practical Alternative to Online Hemodiafiltration

• The MOTheR and CONCORDIA studies show HDx therapy (expanded hemodialysis) enabled by the Theranova dialyzer delivers outcomes comparable to online hemodiafiltration
• Theranova dialyzer's unique design removes large-middle molecules associated with inflammation, cardiovascular disease and other comorbidities, helping achieve filtration closer to the natural kidney
• Findings are further supported by recent data showing HDx therapy is associated with reduced resource utilization, including lower per-session costs and reduced water consumption compared to HDF in provider-based analyses
• HDx therapy supports a modern, coordinated approach to kidney care by expanding access to clinically differentiated hemodialysis without the need for additional infrastructure
   

GLASGOW, Scotland, June 08, 2026 (GLOBE NEWSWIRE) -- Vantive, a vital organ therapy company with a 70-year legacy of kidney care innovation, reports two late-breaking clinical studies indicating HDx therapy (expanded hemodialysis) enabled by the Theranova dialyzer provides similar (statistically non-inferior) all-cause mortality and major cardiovascular outcomes* compared with online hemodiafiltration (OL-HDF).1,2 The randomized controlled MOTheR trial and interim results from the real-world CONCORDIA study were presented at the 63rd European Renal Association (ERA) Congress, held June 3-6, 2026, in Glasgow, Scotland.

While both therapies have shown survival benefits over conventional hemodialysis,3,4 HDx therapy offers a practical alternative to OL-HDF because it can be delivered using existing hemodialysis equipment without additional specialized infrastructure or nurse training. HDx therapy utilizes a medium cut-off membrane that efficiently removes large-middle molecules, allowing for filtration closer to that of the natural kidney.5,6,7,8,9,10,11 These large-middle molecules have been linked to inflammation, cardiovascular disease, and other comorbidities in dialysis patients.5-7,11 

"The MOTheR HDx trial provides the first randomized controlled evidence showing that expanded hemodialysis with medium cut-off membranes performs as well as online hemodiafiltration for cardiovascular and mortality outcomes,” said Patricia de Sequera MD, PhD, nephrology service chief, Hospital Universitario Infanta Leonor, Madrid. “Based on my experience as a practicing physician, this establishes HDx as a clinically valid option, giving nephrologists a technically simpler alternative backed by robust evidence to guide individualized treatment decisions in routine practice." 

Beyond the newly presented studies, a recent provider-perspective analysis from Spain suggests HDx therapy may reduce resource utilization compared with OL-HDF. The study reports per-session cost savings of approximately 8%–18% and approximately 20% lower water consumption, supporting the potential of HDx as a resource-efficient option within modern dialysis care.12

“Collectively, these data reinforce the growing body of evidence supporting HDx therapy as a clinically differentiated and practical option within modern kidney care,” said Peter Rutherford, M.B. BS, Ph.D., head of Worldwide Medical, Vantive. “They also bring sharper focus to a patient-centric approach to kidney care; one built around a coordinated care pathway that prioritizes PD when possible and uses clinically differentiated hemodialysis options, such as HDx therapy, when chosen by the patient or needed for clinical reasons.”

A Closer Look at The New Data

The “MOTheR HDx study: A Multicentre, Open-Label, Prospective, Randomized Study to Explore the Morbidity and Mortality in Patients Dialyzed with the Theranova [Dialyzer and] HDx [Therapy] in Comparison to On-Line Hemodiafiltration” (abstract #27), an investigator-initiated study funded by Vantive, showed that HDx was non-inferior to online hemodiafiltration (OL-HDF) for a composite endpoint* of all-cause mortality and cardiovascular events (IRR 0.87, 95% CI: 0.63–1.19; p = 0.011) in incident hemodialysis patients. For all-cause mortality (one element of the composite endpoint), the incidence rate was 10.7 events per 100 person-years in the HDx therapy group compared to 12.2 in the OL-HDF group — an incidence rate ratio (IRR) of 0.88 (95% CI, 0.60 to 1.27). The point estimate numerically favored HDx therapy, and the confidence interval was fully consistent with comparable survival between HDx therapy and OL-HDF but formal noninferiority for mortality alone was not established statistically (p = 0.062, just above non-inferiority threshold of 1.25). In this multicenter, open-label, randomized study conducted in Spain, 533 patients were followed for up to 36 months.

The “CONCORDIA Study: All-Cause Mortality with Theranova Dialyzer Compared with Hemodiafiltration Using DOPPS as an External Real-World Comparator” (abstract #167), an investigator-initiated study funded by Vantive, interim analysis showed after multivariable adjustment for key demographic, clinical and laboratory variables, the hazard ratio for all-cause mortality of HDx versus HDF  (HR 0.75, 95% CI 0.54–1.04) remained below the prespecified non-inferiority margin, meeting the criteria for non-inferiority. No statistically significant differences in all-cause mortality were observed between modalities. The multinational observational study evaluated patients receiving maintenance hemodialysis and included an interim analysis of 597 patients treated with HDx and 1,339 treated with HDF from a European external comparator cohort (DOPPS), with a median follow-up of 1.6 years. Inclusion of the fully recruited cohort will enable a more definitive assessment of these associations.

The Spain resource utilization analysis, “A resource consumption analysis of expanded hemodialysis compared to online hemodiafiltration: A provider perspective in Spain”, is a micro-costing study conducted from a healthcare provider perspective comparing HDx and OL-HDF. The analysis evaluated resource use and costs per dialysis session and included deterministic and probabilistic sensitivity analyses. Certain cost elements, including personnel and infrastructure investments, were not included and may underestimate differences at the system level.

About Vantive

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams globally. For 70 years, our team has driven meaningful innovations in kidney care. Today, Vantive's people, solutions and services deliver over 1 million touchpoints each day to patients around the world. As we build on our legacy, we are focused on elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Our goal is to provide therapies that fit more easily into providers' practices and patients' lives. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients—that is what Vantive aspires to deliver. For more information, visit www.vantive.com and follow us on LinkedIn, X, Facebook, Instagram and YouTube.

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EU, UK Intended Purpose: Theranova hemodialyzers are intended to purify blood in hemodialysis. CAUTION! Do not use Theranova devices for online hemodiafiltration (OL-HDF) or hemofiltration (HF) due to higher permeability of larger molecular weight proteins such as albumin. Medical devices of class IIb. Notified body: TÜV SÜD (CE 0123). Legal manufacturer: Vantive Health GmbH, Glattpark, Switzerland. Refer to the package leaflet for safe and proper use. Carefully read the Instructions for Use. Date of preparation: December 2024

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

Contact
Vantive
Jill Carey-Hargrave
media@vantive.com

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1 De Sequera P, et al. MOTheR HDx study: A multicentre, open-label, prospective, randomized study to explore the morbidity and mortality in patients dialyzed with the Theranova HDx in comparison to online hemodiafiltration. Presented at: ERA Congress; June 3–6, 2026; Glasgow, Scotland.
2 Pecoits-Filho R, et al. The CONCORDIA study: All-cause mortality with Theranova dialyser compared with hemodiafiltration using DOPPS as an external real-world comparator. Presented at: ERA Congress; June 3–6, 2026; Glasgow, Scotland.
3 Castillo JC, et al. Survival differences in patients with high-flux hemodialysis versus expanded hemodialysis: A cohort study. Blood Purif. 2025:1-10.  doi: 10.1159/000548158.
4 Blankestijn PJ, Vernooij RWM, Hockham C, et al. (2023). Effect of hemodiafiltration or hemodialysis on mortality in kidney failure. New England Journal of Medicine, 389:700–709. https://doi.org/10.1056/NEJMoa2304820.
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10 Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports 2015; 5:18448.
11Ronco C, et al. The rise of Expanded Hemodialysis. Blood Purif. 2017;44:I–VIII. doi: 10.1159/000476012.
12 Rivera A, Vesga J, Sanabria M, et al. (2026). A resource consumption analysis of expanded hemodialysis compared to online hemodiafiltration: A provider perspective in Spain. Nefrologia. https://doi.org/10.1016/j.nefro.2026.501535.