Baxter International, a global innovator in renal care, announced enrollment of first patients in two new clinical trials for a unique expanded hemodialysis (HDx) therapy enabled by Theranova. The US trial is a multi-center, prospective, randomized controlled study to evaluate the effectiveness and safety of Theranova, which will support submission for marketing authorization from the US Food and Drug Administration. In addition, health-related quality of life and the potential to reduce medication use will be assessed.
Baxter's HDx therapy enabled by Theranova was designed to remove large molecular weight toxins that have been associated with inflammation and cardiovascular health for end-stage renal disease (ESRD) patients. The dialyzer is available in select countries around the world including Colombia, where Baxter initiated a second large multi-center, prospective, observational trial designed to understand the impact of removing large uremic toxins on survival and hospitalization.
"These clinical trials allow us to examine the effectiveness and safety of Theranova and assess patient relevant outcomes, including health-related quality of life measures and dialysis symptoms," said Dheerendra Kommala, M.D. vice president Renal Medical Affairs, Baxter. "We are dedicated to building evidence to support this unique innovation in hopes of improving standards of care for ESRD patients who rely on HD to stay alive."
Hemodialysis (HD) therapy is used to treat nearly three million ESRD patients worldwide, and is most often performed three times a week in a clinic. The therapy works by cleaning the blood of toxins and removing extra fluids when it is pumped through an artificial kidney filter or dialyzer, such as Theranova.
HDx therapy extends the range of molecules that can be cleared from the blood during HD, resulting in a clearance profile that more closely mimics the natural kidney. HDx therapy enabled by Theranova is performed during conventional HD therapy, does not require generation of replacement fluid and works on standard equipment for operational efficiencies.
In a previous study published in Nephrology Dialysis Transplantation, researchers found that HDx enabled by the Theranova dialyzer can exceed the performance of other types of dialysis, including high flux hemodialysis and high-volume hemodiafiltration (HDF) for specific large middle molecules, with acceptable albumin removal. Additionally, independent data presented at ERA-EDTA 2017 indicated HDx therapy effectively removed small and mid-sized toxins at similar rates when compared to high-volume HDF using a larger hemofilter.
"Millions of patients with chronic kidney disease rely on renal innovations every day, many of whom have ESRD and require HD therapy to stay alive," said Laura Angelini, general manager, Baxter's Chronic Renal business. "HDx therapy enabled by Theranova was designed to build on Baxter's legacy of providing meaningful innovations, and it is testament of our commitment to supporting the best possible outcomes for HD patients."
HDx enabled by Theranova is available in Europe, select markets in Latin America, the Middle East and Far East, as well as in Australia and New Zealand. It is not yet available for use in the United States.