Baxter International Inc. said it has enrolled the first patients in two new clinical trials for its dialyzer Theranova. The dialyzer is designed to enable expanded dialysis (HDx) and remove large molecular weight toxins in dialysis patients. It’s currently available in Europe, select markets in Latin America, the Middle East and Far East, as well as in Australia and New Zealand. In Colombia, Baxter initiated a second large multi-center, prospective, observational trial designed to understand the impact of removing large uremic toxins on survival and hospitalization for end-stage renal disease patients.
The U.S. trial is a multi- center, prospective, randomized, controlled study to evaluate the effectiveness and safety of Theranova, which will support submission for marketing authorization. Health-related quality of life and the potential to reduce medication use will be assessed.
“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,” said Dheerendra Kommala, M.D. vice president Renal Medical Affairs, Baxter.