Table 3.
Hepcidin levels in patients with chronic kidney disease randomized to receive roxadustat, erythropoiesis-stimulating agent (ESA), or placebo (ng/mL) a.
| Study | Roxadustat | ESA | Placebo |
LSMD (95% CI) |
p Value | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Mean Baseline | LSM CFB (95% CI) |
n | Mean Baseline | LSM CFB (95% CI) |
n | Mean Baseline | LSM CFB (95% CI) | |||
| Chen [11] | 86 | 95.9 | −56.1 (63.4) b | - | - | - | 44 | 114.7 | −15.1 (48.1) b | −49.8 (−66.8, −32.8) | - |
| Chen [10] | BL: 204 Wk 27: 155 |
180.7 | −30.2 (−64.8, −13.6) | BL: 100 Wk 27: 90 |
148.3 | −2.3 (−51.6, 6.2) | - | - | - | - | - |
| CL-0314 [7] | 99 | 24.0 | −5.7 (18.4) b | - | - | - | - | - | - | - | - |
| CL-0310 [6] | 201 | 39.3 | - | 131 | 39.7 | - | - | - | - | - | - |
| CL-0307 c | 150 | 26.4 | 2.3 (27.3) b | 151 | 24.4 | −0.6 (27.1) b | - | - | - | - | - |
| CL-0308 [9] | 74 | 39.8 | −23.2 (22.8) b | - | - | - | - | - | - | - | - |
| CL-0312 [9] | 163 | 28.8 | −6.2 (29.0) b | - | - | - | - | - | - | - | - |
| CL-0302 [8] | ESA-N: 13 ESA-C: 43 |
ESA-N: 63.6 ESA-C: 45.9 |
ESA-N: −31.8 (39.4) b ESA-C: −19.0 (21.6) b |
- | - | - | - | - | - | - | - |
| ALPS [12] | BL: 382 Wk 52: 268 |
37.9 | −12.3 (37.4) b | - | - | - | BL: 195 Wk 52: 114 |
41.2 | −2.0 (40.7) b | - | - |
| OLYMPUS [13] | BL: 1384 Wk 24: 658 |
163.2 | −35.9 (−44.9, −27.0) | - | - | - | BL: 1377 Wk 24: 604 |
155.5 | 9.4 (0.2, 18.7) | −45.4 (−56.2, −34.5) | <0.001 |
| ANDES [14] | BL: 608 Wk 44: 396 |
110.7 | −18.8 (−27.4, −10.3) | - | - | - | BL: 305 Wk 44: 152 |
106.1 | 6.9 (−5.3, 19.1) | −25.7 (−38.5, −12.9) | <0.0001 |
| DOLOMITES [15] d | - | - | - | - | - | - | - | - | - | - | - |
| HIMALAYAS [16] | BL: 522 Wk 44: 356 |
173.2 | −64.8 (−74.3, −55.3) | BL: 513 Wk 44: 372 |
169.9 | −54.1 (−63.4, −44.7) | - | - | - | −10.7 (−23.2, 1.8) | 0.093 |
| ROCKIES [17] | BL: 1051 Wk 24: 608 |
275.6 | −45.0 (−57.5, −32.5) | BL: 1055 Wk 24: 625 |
269.6 | −16.8 (−29.2, −4.4) | - | - | - | −28.2 (−42.0, −14.5) | <0.001 |
| PYRENEES c | 404 | 73.4 | −32.7 (42.3) b | 413 | 80.8 | −17.5 (47.3) b | - | - | - | - | - |
| SIERRAS [19] | BL: 369 Wk 52: 230 |
272.9 | −99.9 (−118.2, −81.6) | BL: 370 Wk 52: 265 |
270.7 | −80.8 (−98.3, −63.3) | - | - | - | −19.1 (−39.5, 1.3) | 0.066 |
Note: n numbers are the same for baseline and CFB unless otherwise specified. CFB, change from baseline; ESA, erythropoiesis-stimulating agent; ESA-N, ESA-naive; ESA-C, ESA-converted; LSM, least squares mean; LSMD, least squares mean difference. a To convert to SI units (nmol/L), multiply numbers by 0.3584. b Change from baseline (standard deviation) rather than least squares mean change from baseline. c Astellas data on file. d Source provides no values for this parameter.