Hemodiafiltration's US Launch: A New Chapter in Kidney Care Technology and Evidence Featured at Kidney Week

Hemodiafiltration (HDF) increases convective clearance by injecting large volumes of sterile replacement fluid into the bloodstream and removing an equivalent volume via ultrafiltration across the dialysis membrane. Earlier this year, Fresenius announced plans for a broad commercial launch of HDF in US markets in 2025 (1).

HDF technology was highlighted in multiple presentations and abstracts during Kidney Week 2024, where Fresenius also held a satellite reception to debut its 5008X dialysis machine. This device is capable of online generation of replacement fluid and allows the delivery of HDF in outpatient dialysis centers without significant retrofitting of the water system. Additionally, Fresenius promoted a new medical education website about HDF, and its latest annual report emphasizes its focus on this technology (2).

Yan Zhang, PhD, of Fresenius Medical Care Deutschland GmbH, Germany, presented an oral abstract of an observational study of over 78,000 patients undergoing dialysis in Fresenius clinics across 23 countries (the United States was not included) (3). Compared with patients receiving standard thrice-weekly, high-flux intermittent hemodialysis (IHD), patients who were treated with HDF had fewer hospitalizations and shorter lengths of stays. Patients undergoing HDF in the higher tertiles of replacement fluid volume had better results.

Peter Blankestjin, PhD, professor at Utrecht University, the Netherlands, presented a new study, simultaneously released in The Lancet, during Kidney Week's late-breaking clinical trials session (4). This was a meta-analysis incorporating data from five randomized trials of HDF versus IHD. The studies are unblinded, as the machines used to deliver the treatments are different. The meta-analysis shows that HDF improves all-cause and cardiovascular mortality. From their summary, “When updated evidence on cost-effectiveness and on patient-reported outcomes is added to this information, it then proves a solid basis for recommendations for a change in clinical practice.”

Immediately after the conclusion of Kidney Week, Fresenius released its 2024 Annual Medical Report (2) including a chapter, entitled “Strategy to Expand High-Volume Hemodiafiltration Worldwide.” The authors note that HDF has been a standard therapy in Fresenius clinics in Europe, North Africa, the Middle East, and Asia since 2004. They cite studies showing multiple benefits of HDF, including improved nutritional status, anemia, and quality of life. The report mentions barriers to more widespread adoption of HDF. Sustainability is an important factor, but the increased water used to generate the replacement fluid may be offset by decreased use of dialysate. While there are upfront costs of the new machines, the authors postulate that long-term use of HDF will generate savings, including avoidance of hospitalizations (with more treatments occurring in centers as a result) and decreased medication expenses. Payment policies differ across countries, but HDF has already been introduced in some countries that do not provide any additional reimbursement for HDF compared with IHD.

The timeline by which Fresenius units will introduce HDF into their US units has not been released, but the company has built significant infrastructure to support the transition. Medical directors and joint venture owners should anticipate discussions about the capital expenditures associated with new machines, as well as training costs for staff. A large-scale shift to HDF would represent one of the first significant changes in dialysis delivery in the past few decades. It remains to be seen if the observed clinical benefits from other countries will be replicated here, and how other dialysis companies choose to respond.

A large-scale shift to HDF would represent one of the first significant changes in dialysis delivery in the past few decades.