Long‐Term Clinical Evaluation of an Adsorbent Column (BM–01) of Direct Hemoperfusion Type for (β2–Microglobulin on the Treatment of Dialysis‐Related Amyloidosis

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Abstract
The clinical efficacy and safety of a β2–microglobulin (β2M) adsorbent column, BM–01, on the treatment of dialysis-related amyloidosis were investigated in 7 hemodialysis patients for more than 6 months. The percent reduction of serum β2M was more than 60–70%, and the level at the end of each session was less than 10 mg/L in almost all patients. The amount of β2M removed was calculated as more than 200–300 mg/session. The results demonstrated that BM–01 performed very well for removing β2M, was capable of maintaining less than 25 mg/L of time average concentration (TAC) for β2M, and improved the clinical symptoms. Clinically severe side effects were not observed. We recommend that BM–01 should undergo further evaluation for its usefulness in the long-term treatment of dialysis-related amyloidosis, though treatment with the column may not be successful in preventing the onset of the disease.