Baxter (NYSE:BAX) today 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.
Results from the trial were presented at the 54th Congress of the European Renal Association and European Dialysis and Transplant Association this week, the company said.
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,” according to a press release.
The 1st study followed 10 patients over 12-months, with patients receiving HDF therapy for the initial 6 months followed by HDx therapy for the following 6 months.
The trial evaluated levels of urea, creatinine, beta-2m and myoglobin in the blood at every 2 months, and found that the HDx therapy was able to clear the 4 molecules associated with kidney failure to a similar extent as the high-volume HDF treatment. Study authors also reported that albumin levels were maintained at similar levels to the HDF therapy period.
“Based on our experience, we believe that treatment with the Theranova dialyzer is a good alternative to HDF treatment. We saw that HDx offers equivalent clearance of middle molecules coupled with the operational simplicity of using standard hemodialysis infrastructure, equipment, protocols and staffing. Additionally, some patients do not tolerate HDF treatment due to its requirements for ideal vascular access to deliver high blood flows,” Dr. Mohamed Belmouaz of France’s CHU Poitiers, Université de Poitiers said in a prepared statement.
A 2nd observational study from Dr. Ugo Teatini of Italy’s ASST Rhodense, Garbagnate followed 8 patients for 5 weeks, measuring pre and post-treatment samples of urea, creatinine, beta2-m, myoglobin, hemoglobin, albumin and total serum protein.
Data from the study showed that HDx therapy offered removal rates for small and medium sized molecules comparable to those during high-volume HDF treatments while maintaining albumin levels.
“We see the new HDx therapy as an excellent option for our patients, in particular in frail hemodialysis patients with a central venous catheter. In these patients, using HDx allows us to administer therapy via the CVC at lower flow rates, whereas HDF would require higher blood flow rates that are hard to attain with a CVC,” Dr. Teatini said in a press release.
Last October, Baxter launched the Theranova HDx hemodialysis system in Australia, New Zealand, France, Germany, Switzerland and Belgium.