Fresenius Medical Care (FME) has announced the publication of a large international study reporting that hemodiafiltration (HDF) was associated with lower relative risk of death from any cause compared with conventional high-flux haemodialysis.
Published in the Journal of the American Society of Nephrology (JASN), the study provides new real-world evidence supporting the role of high-volume hemodiafiltration (HVHDF) in modern dialysis care, Fresenius Medical Care says in a press release.
“This important publication strengthens the growing body of international evidence supporting HVHDF and reflects our commitment to advancing kidney care through large-scale rigorous research and innovation,” said Helen Giza, CEO of Fresenius Medical Care. “With more than 850 million people worldwide affected by kidney disease—nearly 10% of the world’s population—the need for innovation has never been greater. As we expand access to HVHDF in the USA, we remain focused on bringing more patients access to advanced therapies while continuing to generate the evidence needed to improve outcomes and shape the future of dialysis care.”
The study analysed outcomes from nearly 20,000 patients across eight European countries. Investigators used target trial emulation, an analytical approach designed to evaluate real-world clinical data using principles that approximate a randomised clinical trial.
During a median follow-up of 16 months, HDF was associated with a 28% lower relative risk of all-cause mortality than those receiving conventional high-flux haemodialysis. The greatest mortality benefit was seen among patients receiving sustained HDF with convection volumes above 23L per session (HVHDF) with a 33% lower relative risk of death compared with high-flux haemodialysis.
Convection volume measures how effectively HDF treatment removes waste products from the blood, including larger toxins, known as middle molecules, which may contribute to inflammation and other health complications for people living with kidney failure.
According to the company, the findings align with the growing international evidence base supporting HVHDF, including the landmark, EU-funded CONVINCE trial, published in the New England Journal of Medicine and subsequent analyses demonstrating improved survival outcomes and patient-reported outcomes. The new analysis adds important real-world evidence reinforcing the clinical value of HVHDF and highlights the importance of consistently delivering, measuring, and monitoring convection volumes above 23L per treatment session.
“Research is critical to our mission of advancing kidney care,” said Charles Hugh-Jones, global chief medical officer of Fresenius Medical Care. “By partnering with leading investigators, and applying advanced statistical methods to large-scale clinical data, we are helping to generate an ever-increasing evidence base that can translate scientific knowledge into meaningful improvements in treatment delivery and clinical outcomes for patients around the world.”
This research was conducted through an international collaboration involving kidney experts, including Giovanni Strippoli (University of Bari, Bari, Italy) and Bernard Canaud (Montpellier University School of Medicine, Montpellier, France), key contributors to the CONVINCE study; Carmine Zoccali (Kidney Research Institute, New York, USA), a former president of the European Renal Association ERA; internationally recognised epidemiologist Giovanni Tripepi (CNR-IFC, Reggio Calabria, Italy), who led the advanced statistical analyses; and Germaine Wong (University of Sydney, Sydney, Australia), in partnership with Fresenius Medical Care and the Renal Research Institute.
“Using a prespecified target trial emulation with inverse probability weighting and rigorous sensitivity analyses, we closely approximated CONVINCE while reducing measured confounding and other observational biases,” said Zoccali, senior author of the study. “This rigorous methodology strengthens the reliability and clinical relevance of the real-world findings.”
