Table 4.
Group | Observation Period (mo) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | |
Relative ERI (10.0–10.9) rHuEPO | |||||||||||||
VPS-HA | 1.0 | 1.0±0.4 | 1.0±0.6 | 0.9±0.7 | 1.0±0.7 | 1.0±0.8 | 1.1±0.8 | 1.0±0.7 | 1.0±0.7 | 1.1±0.7 | 1.4±1.6 | 1.5±2.2 | 1.2±1.4 |
P (versus 0) | — | 0.82 | 0.11 | 0.06 | 0.39 | 0.48 | 0.74 | 0.90 | 0.67 | 0.69 | 0.28 | 0.88 | 0.62 |
PS-con | 1.0 | 1.2±0.9 | 1.3±0.9 | 1.2±1.0 | 1.2±1.2 | 1.1±1.0 | 1.1±0.9 | 1.2±1.0 | 1.1±1.0 | 1.4±1.4 | 1.5±1.5 | 1.4±1.5 | 1.2±1.3 |
P (versus 0) | — | 0.64 | 0.83 | 0.15 | 0.02a | 0.27 | 0.13 | 0.18 | 0.34 | 0.39 | 0.45 | 0.36 | 0.20 |
P (VPS-HA versus PS-con) | — | <0.001b | <0.001b | <0.001b | <0.001b | <0.01b | <0.001b | <0.01b | <0.01b | <0.01b | <0.01b | <0.01b | <0.01b |
Hb (g/dl, 10.0–10.9) rHuEPO | |||||||||||||
VPS-HA | 10.6±0.8 | 10.6±0.9 | 10.7±1.0 | 10.7±0.9 | 10.7±0.7 | 10.6±0.7 | 10.6±0.9 | 10.5±0.8 | 10.4±0.8 | 10.5±0.9 | 10.6±0.8 | 10.8±0.8 | 10.8±0.9 |
PS-con | 10.7±0.8 | 10.6±0.9 | 10.6±1.0 | 10.8±0.9 | 10.7±0.8 | 10.5±0.9 | 10.5±0.8 | 10.6±0.8 | 10.7±0.8 | 10.6±1.0 | 10.7±1.0 | 10.9±1.0 | 10.9±0.9 |
Relative ERI (10.0–10.9) DA | |||||||||||||
VPS-HA | 1.0 | 1.0±1.3 | 1.0±0.6 | 1.0±0.5 | 1.3±1.1 | 1.1±0.7 | 1.0±0.5 | 1.1±0.7 | 1.1±0.7 | 1.2±1.2 | 0.9±0.6 | 1.1±0.9 | 1.1±0.8 |
P (versus 0) | — | 0.38 | 0.45 | 0.85 | 0.36 | 0.92 | 0.48 | 0.82 | 0.88 | 0.69 | 0.20 | 0.49 | 0.99 |
PS-con | 1.0 | 1.1±0.4 | 1.1±0.7 | 1.3±0.7 | 1.3±0.9 | 1.2±0.8 | 1.1±0.8 | 1.3±0.9 | 1.2±0.9 | 1.2±1.0 | 1.2±1.0 | 1.2±0.9 | 1.2±0.9 |
P (versus 0) | — | 0.96 | 0.75 | 0.27 | 0.94 | 0.75 | 0.94 | 0.26 | 0.48 | 0.59 | 0.49 | 0.35 | 0.39 |
P (VPS-HA versus PS-con) | — | <0.001b | <0.001b | <0.001b | <0.001b | <0.001b | <0.001b | <0.001b | <0.001b | <0.001b | <0.001b | <0.001b | <0.001b |
Hb (g/dl, 10.0–10.9) DA | |||||||||||||
VPS-HA | 10.8±0.8 | 10.7±0.7 | 10.7±0.6 | 10.5±0.8 | 10.4±0.7 | 10.5±0.6 | 10.6±0.8 | 10.4±0.7 | 10.4±0.9 | 10.6±0.9 | 10.7±0.8 | 10.5±1.0 | 10.3±0.7 |
PS-con | 10.7±0.8 | 10.7±0.7 | 10.5±0.9 | 10.6±0.9 | 10.8±1.1 | 10.8±0.8 | 10.7±1.1 | 10.6±0.8 | 10.5±1.2 | 10.6±1.1 | 10.6±0.9 | 10.6±1.0 | 10.4±0.8 |
Relative ERI (11.0–11.9) rHuEPO | |||||||||||||
VPS-HA | 1.0 | 1.2±0.6 | 1.3±0.8 | 1.2±0.8 | 1.4±1.3 | 1.1±0.8 | 1.1±0.6 | 1.4±0.7 | 1.4±0.8 | 1.5±1.0 | 1.5±0.9 | 1.3±0.9 | 1.4±0.9 |
P (versus 0) | — | 0.11 | 0.20 | 0.72 | 0.72 | 0.67 | 0.73 | 0.13 | 0.13 | 0.04a | 0.19 | 0.51 | 0.29 |
PS-con | 1.0 | 1.0±0.3 | 1.0±0.9 | 0.9±0.9 | 1.1±0.8 | 1.5±0.8 | 1.4±0.9 | 1.4±0.9 | 1.3±0.8 | 1.3±0.9 | 1.6±0.9 | 1.5±1.3 | 1.3±0.7 |
P (versus 0) | — | 0.82 | 0.30 | 0.21 | 0.78 | 0.13 | 0.23 | 0.14 | 0.30 | 0.40 | 0.05 | 0.31 | 0.43 |
P (VPS-HA versus PS-con) | — | <0.001b | <0.01b | 0.16 | <0.05a | <0.01b | <0.05a | <0.01b | <0.01b | <0.05a | <0.01b | <0.01b | <0.001b |
Hb (g/dl, 11.0–11.9) rHuEPO | |||||||||||||
VPS-HA | 11.1±1.0 | 11.3±1.0 | 11.3±1.2 | 11.5±0.9 | 11.4±0.7 | 11.3±0.7 | 11.1±0.7 | 10.9±0.8 | 11.1±0.9 | 11.0±0.8 | 11.2±0.6 | 11.3±0.9 | 11.2±1.2 |
PS-con | 11.0±1.0 | 10.9±0.9 | 11.0±1.2 | 11.3±1.0 | 10.8±0.7 | 10.6±0.7 | 10.5±0.9 | 10.6±0.8 | 10.9±0.9 | 11.1±1.0 | 11.0±0.9 | 11.2±0.8 | 11.1±0.8 |
Relative ERI (11.0–11.9) DA | |||||||||||||
VPS-HA | 1.0 | 0.9±0.2 | 0.8±0.4 | 1.0±0.5 | 0.9±0.5 | 0.9±0.5 | 0.9±0.3 | 0.9±0.4 | 0.7±0.3 | 0.7±0.3 | 0.8±0.3 | 0.6±0.3 | 0.7±0.3 |
P (versus 0) | — | 0.65 | 0.16 | 0.49 | 0.10 | 0.16 | 0.23 | 0.22 | 0.02a | <0.001b | 0.04a | <0.001b | <0.001b |
PS-con | 1.0 | 1.3±0.5 | 1.2±0.8 | 1.4±0.9 | 1.3±0.9 | 1.9±0.9 | 1.5±1.0 | 1.3±0.9 | 1.5±0.8 | 1.4±1.0 | 1.5±0.9 | 1.8±0.8 | 1.4±1.0 |
P (versus 0) | — | 0.43 | 0.43 | 0.11 | 0.10 | <0.01b | 0.03a | 0.48 | 0.12 | 0.08 | 0.06 | <0.001b | 0.16 |
P (VPS-HA versus PS-con) | — | <0.001b | <0.01b | <0.01b | <0.001b | <0.001b | <0.001b | <0.01b | <0.01b | <0.01b | <0.01b | <0.001b | <0.01b |
Hb (g/dl, 11.0–11.9) DA | |||||||||||||
VPS-HA | 11.3±0.9 | 11.1±0.6 | 11.2±0.6 | 11.2±0.7 | 11.3±0.9 | 11.0±0.8 | 11.1±0.8 | 11.1±0.9 | 11.3±0.8 | 11.2±1.0 | 11.0±0.8 | 11.0±0.8 | 11.0±0.9 |
PS-con | 11.2±0.9 | 11.0±1.0 | 11.1±0.8 | 11.0±0.7 | 11.3±0.9 | 11.6±1.0 | 11.5±1.1 | 11.4±1.6 | 11.0±1.7 | 11.2±1.2 | 10.9±1.0 | 11.1±0.7 | 11.4±0.8 |
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. Erythropoietic resistance index (ERI) was calculated by dividing total weekly dose of erythropoiesis stimulating-agent (rHuEPO or DA) by hemoglobin level. ERI is expressed as a ratio relative to the baseline level (time 0). Values are mean ± SD. Statistical testing between the VPS-HA and PS-con groups was performed using the Mann–Whitney U test. Statistical testing was performed using repeated measures analysis of covariance followed by Scheffé posthoc test. When there were significant differences between groups, the data of the group with lower ERI were underlined. VPS-HA, vitamin E-bonded high-flux polysulfone dialysis membrane; rHuEPO, human recombinant erythropoietin; PS-con, type 4 polysulfone dialysis membrane; DA, darbepoetin alfa; 10.0–10.9, target hemoglobin range from 10.0 to 10.9 g/dl; 11.0–11.9, target hemoglobin range from 11.0 to 11.9 g/dl.
P<0.05.
P<0.01.