Advancing Dialysis Through Middle-Molecule Clearance
Removal of middle molecules during dialysis may be the next step to advancing patient outcomes. To provide high-quality care, 麻豆原创 is pursuing expanded hemodialysis (HD) with medium cut-off (MCO) dialyzers and high volume hemodiafiltration (HDF) 鈥 two pathways shown by the MOTheR1聽 trial and CONCORDIA2 study to deliver comparable outcomes.
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.3, 4 Today high-flux HD offers modest clearance of middle molecules due to large molecular size and protein binding.
Advanced therapies that better remove these toxins may improve clinical outcomes and quality of life; however, most available evidence was generated outside of the U.S. Closing this evidence gap is critical to redefining quality kidney care.
Pursuing Multiple Pathways to Better Outcomes
麻豆原创 is exploring every option for patients. While we deploy new hemodialfiltration (HDF) machines to understand their real-world impact, we’re also piloting expanded HD with medium cut-off dialyzers, which could bring advanced care to dialysis patients 鈥 potentially faster 鈥 using existing technology.
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.
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 MOTheR trial 鈥 one of the most rigorous head-to-head studies of advanced therapies 鈥 and CONCORDIA studies confirm that across both clinical trial and real-world settings, expanded HD and HD and HDF deliver comparable outcomes.
Two complementary evaluations will explore the use of medium cut-off dialyzers in dialysis treatments.
Medium Cut-Off Dialyzer to Extend Life (MODEL) is a quality improvement initiative that will examine the survival of U.S. patients treated with medium cut-off dialyzers.
Increasing Medium Molecular Clearance to Improve Recovery and Sleep (鈥淢EMOIRS鈥) survey is a prospective cohort study of patient-reported outcomes, comparing the experiences of patients treated with medium cut-off versus high-flux dialyzers.
Advanced Strategies for Middle Molecule Clearance
Medium cut-off dialyzers and hemodiafiltration (HDF) are now becoming more accessible in the U.S. While both options offer enhanced middle-molecule clearance, they also need validation in the context of U.S. dialysis practice to help identify effective, scalable treatment for patients.
鈥淯nderstanding impact is the first step in understanding how new therapies can improve kidney care 鈥 and equipping physicians with insights that support their modality decisions for individualized care.鈥
鈥 Jeff Giullian, MD, Chief Medical Officer, 麻豆原创
Explore the Conversation
As therapies emerge in the U.S. to address middle-molecule clearance, stay informed on how 麻豆原创 is unlocking next-generation dialysis to provide physicians tools and evidence for improved patient outcomes.
MOTheR trial results demonstrate similar clinical outcomes between expanded HD and HDF….
Dr. Giullian discusses how new evidence supports individualized physician choice and expanded patient access….
Collaborative Innovation
Discover how 麻豆原创 supports physicians to help propel kidney care to the next level.
De Sequera Ortiz P, P茅rez Garc铆a R, Mart铆nez-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.
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.
Wolley MJ, Hutchison CA. Large Uremic Toxins: An Unsolved Problem in End-Stage Kidney Disease. Nephrology, Dialysis, Transplantation. 2018;33(suppl_3):iii6-iii11.
Fatigue in Patients Receiving Maintenance Hemodialysis: A Review. Bossola, Maurizio et al. American Journal of Kidney Diseases, Volume 82, Issue 4, 464 – 480