Baxter’s dialyzer, recently granted marketing authorization, may improve hemodialysis
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Study findings showed Baxter’s medium cut-off dialyzer resulted in greater clearance of larger middle molecules than was seen with standard hemodialysis therapy. The device was recently granted de novo authorization by the FDA.
Daniel E. Weiner, MD, MS, of Tufts Medical Center in Boston, told Healio Nephrology that treatment with the dialyzer, known as Theranova 400, also demonstrated safety as there was no change in serum albumin from pre-dialysis levels.
According to Weiner, the results of the trial are “compelling” because they suggest advancements can be made in how hemodialysis is delivered.
“Currently, we believe that the kidney failure milieu contributes to adverse outcomes in dialysis patients, including inflammation, infection and cardiovascular disease,” he said. “Among the many factors influencing this heightened risk, ‘uremic’ solutes represent something that is potentially modifiable. Current hemodialysis technology is good at removing small proteins but is limited when it comes to removing larger middle molecules that could affect outcomes for people with kidney failure.”
For the study, 172 patients on maintenance hemodialysis were randomized to receive treatment with either the Theranova 400 or a high-flux dialyzer (mean age, 59 years; 61% were men; 40% were Black patients; mean time on dialysis, 5 years). The primary efficacy end point was considered as the reduction ratio of lambda free light chains at 24 weeks of treatment.
After 4 weeks, Weiner and colleagues found the reduction ratio for the removal of lambda free light chains was significantly higher in the Theranova 400 group compared with the high-flux dialyzer group (39% vs. 20%). These findings remained consistent after 24 weeks, with patients who received hemodialysis with the Theranova 400 dialyzer achieving a reduction ratio of 33% compared with 17% for those who received treatment with the high-flux dialyzer.
In addition, findings showed patients in the Theranova 400 group had significantly larger reduction ratios for complement factor D, lambda free light chains, TNF-alpha, and beta-2-microglobulin.
Regarding safety, pre-dialysis serum albumin levels were determined to be similar between groups after 24 weeks (4 g/dL with the Theranova 400 vs. 4.1 g/dL with the high-flux dialyzer).
These results indicate there may be a new option for treating an aspect of uremia, according to Weiner.
“Even though dialysis has been widely available for almost 50 years, we still do not understand all of the toxicity associated with kidney failure,” he said. “Hemodialysis patients have a mortality rates similar to many stage 4 cancers, and it is possible that these larger middle molecules contribute to these poor outcomes as well as many of the poorly understood symptoms that may affect quality of life for dialysis patients.”
Adding that it may be continued exposure to the uremic environment over extended periods of time which causes disease, Weiner said it is important further research be conducted in this area. This includes both evaluating long-term outcomes associated with better larger middle molecule clearance, as well as looking at whether there could be a greater benefit in people new to kidney failure, before sustained exposure to these middle molecules.
“We do not yet have a definitive answer, but there is optimism that removing more of these proteins could benefit dialysis patients,” he said.
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