TABLE 1.
Patient demographics and baseline efficacy variables (full analysis set)
| Parameter | ESA‐Naïve Study | ESA‐Converted Study | ||
|---|---|---|---|---|
| Roxadustat 50 mga | Roxadustat 70 mga | All ESA‐Naïve | All ESA‐Converted | |
| N = 37 | N = 37 | N = 74 | N = 163 | |
| Demographics | ||||
| Sex, n (%) | ||||
| Male | 28 (75.7) | 27 (73.0) | 55 (74.3) | 98 (60.1) |
| Female | 9 (24.3) | 10 (27.0) | 19 (25.7) | 65 (39.9) |
| Age (years) | ||||
| Mean (SD) | 65.1 (12.1) | 67.2 (12.2) | 66.2 (12.1) | 62.8 (11.8) |
| Median | 67.0 | 72.0 | 69.0 | 63.0 |
| Range | 38‐83 | 42‐86 | 38‐86 | 28‐91 |
| Age (years), n (%) | ||||
| <65 | 15 (40.5) | 14 (37.8) | 29 (39.2) | 86 (52.8) |
| ≥65 | 22 (59.5) | 23 (62.2) | 45 (60.8) | 77 (47.2) |
| Weight (after hemodialysis) at week 0 (kg) | ||||
| Mean (SD) | 60.60 (12.57) | 62.06 (14.70) | 61.33 (13.60) | 58.35 (12.79) |
| Median | 58.20 | 58.90 | 58.55 | 57.70 |
| Range | 41.9‐95.2 | 39.6‐120.5 | 39.6‐120.5 | 35.3‐109.2 |
| Height (cm) | ||||
| Mean (SD) | 163.23 (10.41) | 160.89 (8.33) | 162.06 (9.44) | 161.30 (9.04) |
| Median | 165.00 | 161.00 | 162.75 | 162.30 |
| Range | 145.3‐185.3 | 144.4‐183.0 | 144.4‐185.3 | 141.0‐181.0 |
| BMI (kg/m2) | ||||
| Mean (SD) | 22.69 (2.65) | 24.04 (4.35) | 23.36 (3.64) | 22.26 (3.69) |
| Median | 22.26 | 22.63 | 22.42 | 21.59 |
| Range | 18.3‐28.6 | 17.6‐36.8 | 17.6‐36.8 | 14.1‐37.4 |
| Duration of anemia of CKDb (months) | ||||
| n | 34 | 33 | 67 | 115 |
| Mean (SD) | 27.07 (24.06) | 24.92 (25.15) | 26.01 (24.44) | 98.40 (69.47) |
| Median | 18.35 | 15.40 | 15.70 | 83.60 |
| Range | 2.0‐84.1 | 0.8‐114.4 | 0.8‐114.4 | 7.6‐366.3 |
| Primary disease of CKD, n (%) | ||||
| Chronic glomerular nephritis | 7 (18.9) | 8 (21.6) | 15 (20.3) | 64 (39.3) |
| Diabetic nephropathy | 14 (37.8) | 17 (45.9) | 31 (41.9) | 54 (33.1) |
| Chronic pyelonephritis | 0 | 0 | 0 | 1 (0.6) |
| Polycystic kidney | 5 (13.5) | 2 (5.4) | 7 (9.5) | 6 (3.7) |
| Nephrosclerosis | 8 (21.6) | 6 (16.2) | 14 (18.9) | 18 (11.0) |
| Other | 3 (8.1) | 4 (10.8) | 7 (9.5) | 20 (12.3) |
| Hemodialysis vintage (days) | ||||
| Mean (SD) | 17.1 (16.6) | 21.8 (20.2) | 19.5 (18.5) | NA |
| Median | 11.0 | 14.0 | 12.0 | |
| Range | 3‐77 | 3‐83 | 3‐83 | |
| Hemodialysis vintage (months) | ||||
| Mean (SD) | NA | NA | NA | 89.69 (78.83) |
| Median | 66.90 | |||
| Range | 3.8‐362.4 | |||
| hs‐CRP (nmol/L) | ||||
| Mean (SD) | 16.964 (26.446) | 37.662 (102.387) | 27.313 (74.988) | 13.038 (22.043) |
| Median | 7.730 | 10.000 | 8.435 | 5.040 |
| Range | 1.01‐143.81 | 0.48‐560.96 | 0.48‐560.96 | 0.48‐163.81 |
| hs‐CRP group (nmol/L), n (%) | ||||
| <28.57 | 32 (86.5) | 28 (75.7) | 60 (81.1) | 144 (88.3) |
| ≥28.57 | 5 (13.5) | 9 (24.3) | 14 (18.9) | 19 (11.7) |
| Baseline efficacy variables | ||||
| Hemoglobin (g/dL)c | ||||
| Mean (SD) | 8.63 (0.77) | 8.67 (0.79) | 8.65 (0.78) | 10.96 (0.57) |
| Median | 8.50 | 8.70 | 8.55 | 11.00 |
| Range | 7.0‐10.0 | 7.0‐10.0 | 7.0‐10.0 | 9.7‐12.3 |
| Iron (μmol/L) | ||||
| Mean (SD) | 12.6 (4.7) | 11.3 (3.6) | 11.9 (4.2) | 12.7 (4.3) |
| Median | 11.0 | 11.0 | 11.0 | 12.0 |
| Range | 6‐25 | 4‐19 | 4‐25 | 5‐27 |
| Ferritin (ng/mL) | ||||
| Mean (SD) | 125.26 (80.37) | 129.02 (89.87) | 127.14 (84.69) | 108.30 (93.18) |
| Median | 98.70 | 110.00 | 106.50 | 87.40 |
| Range | 25.9‐284.0 | 22.1‐422.0 | 22.1‐422.0 | 11.1‐572.0 |
| TSAT (%) | ||||
| Mean (SD) | 30.22 (11.66) | 26.79 (8.51) | 28.51 (10.29) | 29.10 (10.42) |
| Median | 26.50 | 26.30 | 26.40 | 26.60 |
| Range | 13.9‐70.7 | 11.1‐48.3 | 11.1‐70.7 | 8.1‐71.2 |
| CHr (pg) | ||||
| Mean (SD) | 34.43 (2.06) | 33.79 (2.03) | 34.11 (2.05) | 35.03 (2.25) |
| Median | 34.40 | 33.80 | 33.95 | 35.10 |
| Range | 30.3‐39.0 | 26.7‐37.5 | 26.7‐39.0 | 22.5‐39.7 |
| Transferrin (g/L) | ||||
| Mean (SD) | 1.785 (0.286) | 1.785 (0.317) | 1.785 (0.300) | 1.869 (0.333) |
| Median | 1.710 | 1.800 | 1.765 | 1.860 |
| Range | 1.32‐2.68 | 1.05‐2.83 | 1.05‐2.83 | 1.16‐2.96 |
Abbreviations: BMI, body mass index; CHr, reticulocyte hemoglobin; CKD, chronic kidney disease; ESA, erythropoiesis‐stimulating agent; hs‐CRP, high‐sensitivity C‐reactive protein; NA, not applicable; TSAT, transferrin saturation.
a
The initial dose only.
b
The diagnosis and time of onset of CKD anemia were confirmed by a physician.
c
Defined as the mean of three Hb values: two latest Hb values prior to registration and one Hb value at week 0.