Baxter International, a global innovator in kidney care, has advanced scientific exchange with 14 new data presentations about the role innovation plays in increasing access to and quality of home dialysis and expanded haemodialysis (HDx) care at American Society of Nephrology (ASN) Kidney Week 2022 (3–6 November, Orlando, USA).
One study has been presented indicating a significant reduction in all-cause mortality and fluid balance, and cardiovascular and metabolic related adverse events, in home automated peritoneal dialysis (APD) patients with Sharesource remote patient management (RPM) versus APD patients without RPM, “Adverse Events and Hospitalizations with Remote Patient Monitoring of Patients on Automated Peritoneal Dialysis“.
Secondly, a simulated dialysis study indicating expanded haemodialysis (HDx) enabled by Theranova demonstrates the best balance when aiming to achieve higher clearance of larger molecular weight middle molecules while minimising albumin loss, “On the Removal of Middle Molecules and Albumin Loss: An Ex Vivo Evaluation of Commercial Dialyzers”.
Baxter’s Sharesource RPM digital health platform allows healthcare professionals to monitor their patients’ home dialysis treatments, and then remotely adjust therapy without the need for patients to make unplanned visits to the clinic. Sharesource is currently serving more than 50,000 patients, across more than 70 countries on Baxter’s APD cyclers. The RPM study presented at ASN Kidney Week 2022 was a cluster randomised controlled trial, at 21 hospitals across Mexico, where care units were randomly assigned to treat their APD patients with or without RPM.
HDx enabled by Theranova removes a wider range of molecules from the blood than traditional HD filters, like high-flux membranes, by targeting the effective removal of large middle molecules (up to 45,000 Da) while selectively retaining essential proteins and maintaining stable albumin levels. These middle molecules have been linked to the development of inflammation, cardiovascular disease, and other co-morbidities in dialysis patients.
The new Theranova data come from a simulated study that evaluated the challenges associated with increased removal of larger middle molecules while avoiding clinically relevant albumin loss during a dialysis session. During the study, four commercial dialyzers with comparable surface areas were carefully evaluated for solute clearance and albumin loss during four-hour simulated haemodialysis treatments under standardised conditions.
Theranova had significantly higher small and large middle molecule clearance (up to 2-3 times higher for YKL40) than two of the other dialyzers as well as lower albumin loss. One dialyzer cleared a higher volume of large middle molecules, but demonstrated albumin loss more than double that observed with Theranova. The study shows further assessment of the dialyzer’s performance in clinic studies is necessary to better understand the benefits of these findings.
HDx enabled by Theranova is currently available in 54 countries across Europe, Latin America, Asia, Africa, and in the USA and Canada. More than nine million dialysis treatments have been performed worldwide using Theranova in more than 850 clinics. The US Food and Drug Administration granted Theranova a de novo application in 2020, which established it as a new class of dialyzer technology with unique performance standards.
The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent haemodialysis. It provides an expanded solute removal profile with increased removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. The Theranova Dialyzer is not intended for haemofiltration or haemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient’s blood volume.
