Baxter International Inc. highlighted new data from two studies presented at Kidney Week on its expanded hemodialysis (HDx) therapy enabled by the Theranova dialyzer. The studies were conducted by clinicians in the United Kingdom and Germany.
Theranova is designed to enable 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.
HDx is performed the same way as conventional hemodialysis, does not require generation of replacement fluid and works on standard equipment for operational efficiencies. Baxter said in October that it had enrolled the first patients in two new U.S. clinical trials for its Theranova.
“We found that HDx therapy was convenient and simple to implement at our hospitals,” said Jyoti Baharani, M.D., one of the lead abstract authors from Heart of England NHS Foundation Trust, Birmingham, UK “The therapy is promising because it offers effective clearance of middle molecules. This is especially important for patients who are unable to get the prescribed dose of hemodiafiltration.”
Clinicians at Heartlands Hospital and Morristown Hospital compared clearance of β2m, a mid-weight toxin, and albumin levels between HDx and high-flux hemodialysis (HD), and HDx and hemodiafiltration (HDF). At Heartlands Hospital, patients were switched from high-flux HD using the FX60 or FX80 dialyzer to HDx therapy with the Theranova dialyzer.
Following nine weeks of HDx therapy, pre-dialysis levels of β2m were reduced by 11.7%, on average, and no difference in serum albumin level was seen. At Morristown Hospital, the study included 14 patients who failed to tolerate HDF and four who had tolerated HDF. The study demonstrated HDx and HDF were able to effectively remove β2m, with minimal albumin loss.
“HDx therapy was convenient, simple to implement, and achieved high β2M RRs with low albumin loss,” the study authors wrote. “It offers opportunity for achieving the clearance of middle molecules delivered by HDF, when patient factors exist or HDF is not available.”
Clinicians in Rostock, Germany compared HDx and HDF in 32 patients undergoing dialysis. The study focused on the extent to which each therapy improved albumin binding capacity (ABiC) and removed uremic toxins.
Patients in the study were treated with six HDF treatments, followed by six HDx treatments. Blood samples taken throughout the study period showed HDx and HDF treatments to provide similar improvements in ABiC and to be similarly effective in reducing levels of uremic toxins. Additionally, albumin concentration remained steady during HDx treatment.
“Expanded hemodialysis enabled by Theranova demonstrates equal effects on ABIC and uremic toxins in comparison to [online hemodiafiltration],” the study authors wrote.