Long-term clinical evaluation of an adsorbent column (BM-01) of direct hemoperfusion type for beta 2-microglobulin on the treatment of dialysis-related amyloidosis

The clinical efficacy and safety of a beta 2-microglobulin (beta 2M) 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 beta 2M 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 beta 2M removed was calculated as more than 200-300 mg/session. The results demonstrated that BM-01 performed very well for removing beta 2M, was capable of maintaining less than 25 mg/L of time average concentration (TAC) for beta 2M, 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.