Clinical evaluation of performance, biocompatibility, and safety of vitamin E-bonded polysulfone membrane hemodialyzer compared to non-vitamin E-bonded hemodialyzer

Abstract

The vitamin E-bonded polysulfone membrane hemodialyzer (ViE™-21) was evaluated in a clinical study for regulatory submission. Seventeen patients on hemodialysis were treated with conventional high-flux hemodialyzers for 2 weeks (Pre-ViE phase) and switched to the ViE-21 for 36 sessions (ViE phase) followed by an additional 2 weeks on conventional hemodialyzers (Post-ViE phase). Reduction ratios of urea, creatinine, beta-2-microglobulin, albumin, and ultrafiltration coefficients (KUF) were measured once during the Pre-ViE phase and twice during the ViE phase. Moreover, biocompatibility markers [leucocyte count, platelet count, and activated complement factor (C3a) levels] were evaluated pre-dialysis, 15 min after initiation, and post-dialysis. During the study, type and number of adverse events (AEs), and device malfunctions were recorded. ViE-21 reduction ratios and KUF were not noticeably different than those of conventional hemodialyzers. Fluctuations of leucocyte counts and C3a concentrations were similar using ViE-21 and conventional hemodialyzers; however, the platelet count fluctuation was lower in ViE-21 sessions. The frequency of episodes of hypotension occurring during the ViE phase was lower than that occurring during the Pre- and Post-ViE phases. In conclusion, this study provided performance and safety data of the ViE-21 for regulatory application. The data suggest that vitamin E-bonded hemodialyzers are beneficial in lowering platelet activation and frequency of intradialytic hypotension. Larger randomized controlled trials are needed to confirm these findings.

Keywords: Adverse event; Good clinical practice; Hemodialysis; Intradialytic hypotension; Platelet.

Fig. 1

Fluctuation of biocompatibility markers during the dialysis sessions for the intent-to-treat (ITT) population. Figures a, b, and c correspond to fluctuations of leucocyte, platelet, and C3a, respectively. Open circles, filled circles, and filled squares indicate measurements at the Pre-ViE phase, ViE phase 1st measurement, and ViE phase 2nd measurement, respectively. The 15 min after initiation and post-dialysis values were first normalized by defining the pre-dialysis values as baseline (100%) and using the hematocrit correction equation. The changes (%) at 15 min and post-dialysis are shown in the figure by indicating the pre-dialysis point as 0%. The bars indicate standard errors and P values indicate the results of paired t test compared to the Pre-ViE phase