Baxter (NYSE:BAX) said today it launched 2 new clinical trials exploring expanded HDx hemodialysis therapy using its Theranova dialyzer.
The Deerfield, Ill.-based company’s HDx therapy uses a Theranova dialyzer designed to extend the range of molecules that it filters from the blood, claiming it “more closely mimics the natural kidney.” The therapy works on standard equipment and does not require the generation of replacement fluid, Baxter said.
“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. 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,” Baxter chronic renal biz GM Laura Angelini said in a prepared statement.
Baxter said it enrolled the 1st patients in both trials, including a US-based multi-center trial looking to evaluate the safety and effectiveness of Theranova in hopes of supporting FDA approval. The 2nd trial is taking place in Colombia, exploring 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. 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,” Baxter renal medical affairs VP Dr. Dheerendra Kommala said in a press release.
In June, Baxter released data from 2 independent studies of its novel HDx therapy using the Theranova dialyzer, touting the effective removal of small and mid-sized toxins at similar rates compared to hemodiafiltration.