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

Mercedeh Kiaii, Masaharu Aritomi, Mitsuyo Nagase, Myriam Farah, Beverly Jung, Mercedeh Kiaii, Masaharu Aritomi, Mitsuyo Nagase, Myriam Farah, Beverly Jung

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.

Conflict of interest statement

The study was financially supported by Asahi Kasei Medical Co., Ltd. M. Aritomi and M. Nagase are employees of Asahi Kasei Medical Co., Ltd. There are no other conflicts of interests for this study.

Figures

Fig. 1
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

References

    1. Bowry SK. Nano-controlled membrane spinning technology: regulation of pore size, distribution and morphology of a new polysulfone dialysis membrane. Contrib Nephrol. 2002;137:85–94. doi: 10.1159/000060234.
    1. Krane V, Krieter DH, Olschewski M, et al. Dialyzer membrane characteristics and outcome of patients with type 2 diabetes on maintenance hemodialysis. Am J Kidney Dis. 2007;49:267–275. doi: 10.1053/j.ajkd.2006.11.026.
    1. Del Vecchio L, Locatelli F, Carini M. What we know about oxidative stress in patients with chronic kidney disease on dialysis-clinical effects, potential treatment, and prevention. Semin Dial. 2011;24:56–64. doi: 10.1111/j.1525-139X.2010.00819.x.
    1. Galli F. Vitamin E-modified dialyzers. Contrib Nephrol. 2002;137:95–105. doi: 10.1159/000060235.
    1. Floridi A, Piroddi M, Pilolli F, Matsumoto Y, Aritomi M, Galli F. Analysis method and characterization of the antioxidant capacity of vitamin E-interactive polysulfone hemodialyzers. Acta Biomater. 2009;5:2974–2982. doi: 10.1016/j.actbio.2009.04.011.
    1. Aritomi M, Galli F. Review of the effectiveness of cellulose- and polysulfone-based vitamin E-bonded dialysis membranes. In: Technical problems in patients on hemodialysis (Intech open access book), 2011; 17, 295–302.
    1. Piroddi M, Pilolli F, Aritomi M, Galli F. Vitamin E as a functional and biocompatibility modifier of synthetic hemodialyzer membranes: an overview of the literature on vitamin E-modified hemodialyzer membranes. Am J Nephrol. 2012;35:559–572. doi: 10.1159/000338807.
    1. Yamadera S, Nakamura Y, Inagaki M, et al. Vitamin E-coated dialyzer inhibits oxidative stress. Blood Purif. 2017;44:288–293. doi: 10.1159/000478971.
    1. FDA Guidance for Industry and CDRH Reviewers (1998) Guidance for the content of premarket notifications for conventional and high permeability hemodialyzers
    1. ISO 14155 (2011) Clinical investigation of medical devices for human subjects—good clinical practice, Second edition
    1. Aoun B, Janssen-Lozinska Y, Ulinski T. Effect of vitamin E coated dialyzers on anticoagulation requirement in hemodialyzed children. Saudi J Kidney Dis Transpl. 2010;21:466–470.
    1. Torato T, Doi K, Negishi K, et al. Efficacy of vitamin E-bonded polysulfone dialyzer and polysulfone dialyzer on a series of non-anticoagulant hemodialysis. ASAIO. 2013;59:284–285. doi: 10.1097/MAT.0b013e318289b975.
    1. Islam MS, Hassan ZA, Chalmin F, et al. Vitamin E-coated and heparin-coated dialyzer membranes for heparin-free hemodialysis: A multicenter, randomized, crossover trial. Am J Kidney Dis. 2016;68:752–762. doi: 10.1053/j.ajkd.2016.05.013.
    1. Tsukao H, Kokubo K, Takahashi H, et al. Activation of platelets upon contact with a vitamin E-coated/non-coated surface. J Artif Organs. 2013;16:193–205. doi: 10.1007/s10047-013-0686-4.
    1. Matsumura M, Sasaki H, Sekizuka K, et al. Improved management of intradialytic hypotension (IDH) using vitamin E-bonded polysulfone membrane dialyzer. Int J Artif Organs. 2010;33:147–153. doi: 10.1177/039139881003300303.
    1. Koremoto M, Takahara N, Takahashi M, et al. Improvement of intradialytic hypotension in diabetic hemodialysis patients using vitamin E-bonded polysulfone membrane dialyzers. Artif Organs. 2012;36:901–910. doi: 10.1111/j.1525-1594.2012.01483.x.
    1. Andrulli S, Di Filippo S, Manzoni C, et al. Effect of synthetic vitamin E-bonded membrane on responsiveness to erythropoiesis-stimulating agents in hemodialysis patients: a pilot study. Nephron Clin Pract. 2010;115:c82–c89. doi: 10.1159/000294281.
    1. Panichi V, Rosati A, Paoletti S, et al. A vitamin E-coated polysulfone membrane reduces serum levels of inflammatory markers and resistance to erythropoietin-stimulating agents in hemodialysis patients: results of a randomized cross-over multicenter trial. Blood Purif. 2011;32:7–14. doi: 10.1159/000321369.
    1. Mandolfo S, Corradi B, Bucci R, Farina M, Pilolli F, Galli F. Evaluation of the impact of a new synthetic vitamin E-bonded membrane on anemia and rHuEPO requirement in ESRD patients with central venous catheters: a pilot study. Int Urol Nephrol. 2012;44:1493–1500. doi: 10.1007/s11255-011-0016-9.
    1. Lines SW, Carter AM, Dunn EJ, Lindley EJ, Tattersall JE, Wright MJ. A randomized controlled trial evaluating the erythropoiesis stimulating agent sparing potential of a vitamin E-bonded polysulfone dialysis membrane. Nephrol Dial Transplant. 2014;29:649–656. doi: 10.1093/ndt/gft481.
    1. Sanaka T, Mochizuki T, Kinugasa E, et al. Randomized controlled open-label trial of vitamin E-bonded polysulfone dialyzer and erythropoiesis-stimulating agent response. Clin J Am Soc Nephrol. 2013;8:969–978. doi: 10.2215/CJN.04680512.
    1. Bargnoux AS, Cristol JP, Jaussent I, et al. Vitamin E-coated polysulfone membrane improved red blood cell antioxidant status in hemodialysis patients. J Nephrol. 2013;26:556–563. doi: 10.5301/jn.5000195.
    1. Locatelli F, Andrulli S, Viganò SM, et al. Evaluation of the impact of a new synthetic vitamin E-bonded membrane on the hypo-responsiveness to the erythropoietin therapy in hemodialysis patients: a multicenter study. Blood Purif. 2017;43:338–345. doi: 10.1159/000453442.
    1. D'Arrigo G, Baggetta R, Tripepi G, Galli F, Bolignano D. Effects of vitamin E-coated versus conventional membranes in chronic hemodialysis patients: a systematic review and meta-analysis. Blood Purif. 2016;43:101–122. doi: 10.1159/000453444.
    1. Morimoto H, Nakao K, Fukuoka K, et al. Long-term use of vitamin E-coated polysulfone membrane reduces oxidative stress markers in hemodialysis patients. Nephrol Dial Transplant. 2005;20:2775–2782. doi: 10.1093/ndt/gfi121.
    1. Calò LA, Naso A, D'Angelo A, et al. Molecular biology-based assessment of vitamin E-coated dialyzer effects on oxidative stress, inflammation, and vascular remodeling. Artif Organs. 2011;35:E33–E39.
    1. Kitamura Y, Kamimura K, Yoshioka N, et al. The effect of vitamin E-bonded polysulfone membrane dialyzer on a new oxidative lipid marker. J Artif Organs. 2013;16:206–210. doi: 10.1007/s10047-013-0689-1.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit