Table 1.
Demographic and baseline characteristics (safety population)a
| Characteristic | Epoetin alfa-epbx n = 122 | Epoetin alfa n = 122 |
|---|---|---|
| Male, n (%) | 63 (51.6) | 55 (45.1) |
| Age, yr, mean (SD) | 57.36 (11.93) | 56.50 (13.42) |
| Race, n (%) | ||
| White | 69 (56.6) | 58 (47.5) |
| Black or African American | 48 (39.3) | 60 (49.2) |
| Native Hawaiian or other Pacific Islander | 0 | 1 (0.8) |
| Asian | 4 (3.3) | 2 (1.6) |
| American Indian or Alaska Native | 1 (0.8) | 1 (0.8) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 34 (27.9) | 31 (25.4) |
| Not Hispanic or Latino | 88 (72.1) | 91 (74.6) |
| Weight, kg, mean (SD) | 85.04 (22.88) | 86.59 (25.18) |
| Time from start of dialysis to randomization, mo, mean (SD) | 54.25 (52.44) | 57.94 (41.52) |
| Hemoglobin level, g/dl, mean (SD) | 10.36 (0.78) | 10.28 (0.78) |
| Weekly epoetin dose by BW, U/kg per wk, mean (SD) | 93.53 (112.45)b | 85.91 (82.08) |
| Ferritin level, ng/ml, mean (SD) | 990.9 (413.37) | 927.7 (396.81) |
| TSAT, %, mean (SD) | 36.1 (13.40) | 34.2 (14.50) |
| Anti-rhEPO antibody status, n (%) | ||
| Negative RIP | 108 (88.5) | 104 (85.2) |
| Positive RIP | 1 (0.8) | 1 (0.8) |
| Missingc | 13 (10.7) | 17 (13.9) |
| Primary cause of CKD, n (%)d | ||
| Diabetes | 56 (45.2) | 41 (33.6) |
| Hypertension | 43 (34.7) | 58 (47.5) |
| Nephropathies | 13 (10.5) | 16 (13.1) |
| Congenital renal disease | 5 (4.0) | 3 (2.5) |
| Other | 7 (5.6) | 4 (3.3) |
Anti-rhEPO, anti-recombinant human erythropoietin antibody; BW, body weight; CKD, chronic kidney disease; ITT, intent-to-treat; RIP, radioimmunoprecipitation assay; TSAT, transferrin saturation.
Analyses for all characteristics except primary cause of CKD were performed on the safety population for the maintenance phase. The percentages for ‘race’ may not add up to 100 because patients could select multiple races. Baseline was the last value determined before first dose of study drug in the maintenance phase.
Mean (SD) weekly epoetin dose by BW (U/kg per wk) based on data for 121 patients treated with epoetin alfa-epbx.
Baseline anti-rhEPO antibody samples were missing because of sample not being drawn or sample handling. Missing samples were to be redrawn at the following visit, but were not considered baseline values.
Analyses for primary cause of CKD were performed using the ITT population (epoetin alfa-epbx, n = 124; epoetin alfa, n = 122).