Randomized controlled open-label trial of vitamin E-bonded polysulfone dialyzer and erythropoiesis-stimulating agent response

Abstract

Background and objectives: A 1-year multicenter prospective randomized controlled study was conducted on the effects of vitamin E-bonded polysulfone dialyzers on erythropoiesis-stimulating agent response in hemodialysis patients.

Design, setting, participants, & measurements: Major inclusion criteria were use of high-flux polysulfone dialyzers with 50-70 ml/min β2-microglobulin clearance over 3 months, transferrin saturation over 20%, same erythropoiesis-stimulating agent for over 3 months, and hemoglobin at 10-12 g/dl. Hemodialysis patients were placed in four interventional groups: two hemoglobin ranges (10.0-10.9 or 11.0-11.9 g/dl) and two dialyzers. Patients were randomly assigned by central registration to a vitamin E-bonded polysulfone dialyzers or polysulfone control group. Primary end point was relative erythropoiesis resistance index at baseline between groups at 12 months. Erythropoiesis resistance index was defined as total weekly erythropoiesis-stimulating agent dose divided by hemoglobin.

Results: There were no statistically significant differences in age or sex. There was no significant difference in relative erythropoiesis resistance index between vitamin E-bonded polysulfone dialyzers and control groups at 12 months (vitamin E-bonded polysulfone dialyzers: 1.1, control: 1.3). The vitamin E-bonded polysulfone dialyzers group showed better relative erythropoiesis resistance index than the control group at 11.0-11.9 g/dl hemoglobin (vitamin E-bonded polysulfone dialyzers: 1.0, control: 1.4 at 12 months, significant difference) but no difference at 10.0-10.9 g/dl hemoglobin.

Conclusions: The overall relative erythropoiesis resistance index showed no difference between the vitamin E-bonded polysulfone dialyzers and control groups, although the change in relative erythropoiesis resistance index differed according to hemoglobin level.

Figure 1.

Outline of protocol. Each patient was allocated to target hemoglobin range depending on one’s prestudy level of hemoglobin measured for 3 months, and the target hemoglobin level was kept during this trial. ESA, erythropoiesis-stimulating agent; Hb, hemoglobin level, PS-con, type 4 polysulfone membrane; VPS-HA, vitamin E-bonded high-flux polysulfone dialysis membrane.

Figure 2.

Patient disposition. Each patient was allocated to target hemoglobin range depending on one’s prestudy level of hemoglobin measured for 3 months, and the target hemoglobin level was kept during this trial. Death, cardiovascular, cerebrovascular, malignant tumor, and others as content; deviation from protocol, changing the type of erythropoiesis-stimulating agent (ESA), inadequate ESA dose, and dialyzer related as content; Hb, hemoglobin; hemorrhage, gastrointestinal hemorrhage; PS-con, type 4 polysulfone membrane; rHuEPO, human recombinant erythropoietin; transplant, renal transplantation, others, or change of hospital (patient factor); VPS-HA, vitamin E-bonded high-flux polysulfone dialysis membrane; 10.0–10.9, hemoglobin range of 10.0–10.9 g/dl as target hemoglobin; 11.0–11.9, hemoglobin range of 11.0–11.9 g/dl as target hemoglobin.