Demographic and baseline characteristics of patients with ESKD and anemia enrolled in a comparative clinical trial of epoetin alfa-epbx versus epoetin alfa
| Characteristica | Epoetin alfa-epbx, n=301 | Epoetin alfa, n=304 |
|---|---|---|
| Men, n (%) | 156 (52) | 175 (58) |
| Age, mean (SD), yr | 55 (13) | 57 (11) |
| Race, n (%) | ||
| White | 141 (47) | 150 (49) |
| Black | 146 (49) | 125 (41) |
| Native Hawaiian or other Pacific Islander | 2 (0.7) | 4 (1) |
| Asian | 4 (1) | 13 (4) |
| American Indian or Alaska Native | 0 | 1 (0.3) |
| Other | 8 (3) | 10 (3) |
| Missing | 0 | 1 (0.3) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 94 (31) | 99 (33) |
| Not Hispanic or Latino | 207 (69) | 204 (67) |
| Missing | 0 | 1 (0.3) |
| Weight, mean (SD), kg | 87 (24) | 86 (22)b |
| Time from start of dialysis to randomization, mean (SD), mo | 51 (51) | 54 (51) |
| Hemoglobin level, mean (SD), g/dl | 10.4 (0.8)c | 10.4 (0.7) |
| Weekly epoetin dose by body weight, mean (SD), U/kg per week | 106 (98) | 108 (104)b |
| Dose frequency, per week, n (%) | ||
| 1 | 72 (24) | 74 (24) |
| 2 | 47 (16) | 53 (17) |
| 3 | 182 (60) | 178 (59) |
| Ferritin level, mean (SD), ng/ml | 921 (437) | 937 (419) |
| TSAT, mean (SD), % | 34 (12) | 33 (11) |
| C-reactive protein, mean (SD), mg/dl | 1.0 (1.9) | 1.0 (1.5) |
| Anti-rhEPO antibody status, n (%) | ||
| Negative RIP | 267 (89) | 262 (86) |
| Positive RIP | 2 (0.7) | 3 (0.99) |
| Missingd | 32 (11) | 39 (13) |
| Primary cause of CKD,e n (%) | ||
| Diabetes | 145 (47) | 151 (49) |
| Hypertension | 105 (34) | 85 (28) |
| Nephropathies | 36 (12) | 44 (14) |
| Congenital kidney disease | 6 (2) | 10 (3) |
| Other | 10 (3) | 12 (4) |
| Unknown | 3 (0.98) | 3 (0.98) |
TSAT, transferrin saturation; anti-rhEPO, anti-recombinant human erythropoietin antibody; RIP, radioimmunoprecipitation assay.
↵a Analyses for all characteristics except for primary cause of CKD were performed on the safety population. The percentages for race may not add up to 100 because patients could select multiple races and because of rounding. Percentages for other characteristics also may not add up to 100 because of rounding.
↵b Mean (SD) weight on the basis of data for 303 patients treated with epoetin alfa.
↵c Mean (SD) hemoglobin level on the basis of data for 300 patients treated with epoetin alfa-epbx.
↵d Baseline anti-rhEPO antibody samples were missing because of the sample not being drawn or sample handling. Missing samples were to be redrawn at the following visit, but were not considered baseline values.
↵e Analyses for primary cause of CKD were determined using the intent-to-treat population (epoetin alfa-epbx, n=306; epoetin alfa, n=306).