Table 1.

Baseline characteristics of participants in a randomized, clinical trial evaluating the efficacy (noninferiority) and safety of daprodustat compared with darbepoetin alfa in Japanese patients on hemodialysis (safety population)

CharacteristicDaprodustat, n=136Darbepoetin Alfa, n=135
Sex, n (%)
 Male91 (67)89 (66)
Age, yr, mean±SD64±1064±11
BMI, kg/m2, mean±SD22±3.823±4.2
Prior ESA type, n (%)
 Epoetin53 (39)58 (43)
 Darbepoetin alfa70 (51)64 (47)
 Epoetin beta pegol13 (10)13 (10)
Prior ESA dose, IU/wk, mean±SDa4504±23184501±2474
ERI, IU/kg per wk per g/dl, n (%)b,c
 Tertile 1: <4.7941/133 (31)48/134 (36)
 Tertile 2: ≥4.79 and <845/133 (34)44/134 (33)
 Tertile 3: ≥8.047/133 (35)42/134 (31)
Time on dialysis, yr, mean±SD7.9±6.97.9±7.1
Mode of dialysis, n (%)
 Hemodialysis86 (63)88 (65)
 Hemodiafiltration50 (37)47 (35)
Hgb, g/dl, mean±SDc10.9±0.810.8±0.7
Iron parametersc
 Serum iron, µg/dl, mean (SD)68 (25)65 (23)
 TIBC, µg/dl, mean (SD)254 (39)249 (38)
 TSAT, %, mean (SD)27.0 (10.1)26.3 (8.9)
 Ferritin, µg/L, geometric mean (CV %)86.5 (108.9)96.6 (124.5)
 Hepcidin, ng/ml, geometric mean (CV %)54.1 (107.9)60.1 (105.0)
Hypertension, n (%)127 (93)125 (93)
Hyperlipidemia, n (%)57 (42)60 (44)
Diabetes mellitus, n (%)56 (41)52 (39)
Angina, n (%)23 (17)39 (29)
Eye disorders, n (%)52 (38)42 (31)
 Diabetic retinopathy39 (29)39 (29)
 Macular edema8 (6)5 (4)
 Age-related macular degeneration5 (4)8 (6)
  • BMI, body mass index; ESA, erythropoiesis-stimulating agent; ERI, erythropoietin resistance index; Hgb, hemoglobin; TIBC, total iron-building capacity; TSAT, transferrin saturation; CV, coefficient of variation; IV, intravenous; SC, subcutaneous; ITT, intent-to-treat.

  • a Standardized to epoetin IV dose (IU/wk) as follows: epoetin SC dose (IU/wk) multiplied by 116/113; darbepoetin alfa dose (μg/wk) multiplied by 250; epoetin beta pegol dose (μg/wk) multiplied by 208.

  • b ERI (IU/kg per week per g/dl)=standardized prior ESA dose (IU/wk)/baseline weight (kg)/baseline Hgb (g/dl).

  • c ITT population.