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Table 1 Demographic and Baseline Characteristics (ITT Population)

From: A randomized, 29-day, dose-ranging, efficacy and safety study of daprodustat, administered three times weekly in patients with anemia on hemodialysis

 

Placebo

n = 18

Total Daprodustat

n = 79

Daprodustat Dose

10 mg

n = 20

15 mg

n = 18

25 mg

n = 21

30 mg

n = 20

Age (years)

 Mean ± SD

60.9 ± 13.3

64.1 ± 15.0

63.6 ± 17.0

59.1 ± 12.7

67.2 ± 15.2

65.9 ± 14.3

Sex, n (%)

 Male

7 (39)

50 (63)

12 (60)

13 (72)

12 (57)

13 (65)

Race, n (%)

 White

12 (67)

53 (67)

12 (60)

11 (61)

15 (71)

15 (75)

 African American

6 (33)

21 (27)

6 (30)

6 (33)

5 (24)

4 (20)

 Asian

0

2 (3)

1 (5)

1 (6)

0

0

 Other

0

3 (4)

1 (5)

0

1 (5)

1 (5)

Weight (kg)

 Mean ± SD

82.8 ± 26.5

78.8 ± 22.5

79.8 ± 26.0

79.8 ± 22.3

79.1 ± 24.3

76.3 ± 18.1

BMI (kg/m2)

 Mean ± SD

30.6 ± 8.6

28.2 ± 7.5

28.7 ± 8.6

27.4 ± 7.8

29.4 ± 7.4

27.1 ± 6.4

Diabetes, n (%)

 Yes

9 (50)

35 (44)

6 (30)

8 (44)

9 (43)

12 (60)

Hgb (g/dL)

 Mean ± SD

10.6 ± 0.8

10.6 ± 0.7

10.6 ± 0.7

10.7 ± 0.8

10.4 ± 0.6

10.5 ± 0.7

Stratification factor, n (%)

 Low prior rhEPO dosea

14 (78)

59 (75)

15 (75)

14 (78)

16 (76)

14 (70)

 High prior rhEPO doseb

4 (22)

20 (25)

5 (25)

4 (22)

5 (24)

6 (30)

Type of rhEPO, n (%)

 Darbepoetin

1 (6)

20 (25)

4 (20)

3 (17)

7 (33)

6 (30)

 Epoetin

17 (94)

59 (75)

16 (80)

15 (83)

14 (67)

14 (70)

Standardized prior rhEPO dose (IU/kg/week)

 Mean ± SD

66.8 ± 43.1

86.6 ± 88.4

108.0 ± 147.1

75.0 ± 41.3

69.4 ± 51.2

93.7 ± 72.0

Smoking history,c n (%)

N = 19

N = 84

N = 20

N = 20

N = 22

N = 22

 Never

15 (79)

54 (64)

14 (70)

13 (65)

15 (68)

12 (55)

 Current

1 (5)

4 (5)

2 (10)

1 (5)

0

1 (5)

 Former

3 (16)

26 (31)

4 (20)

6 (30)

7 (32)

9 (41)

Mode of dialysis,c n (%)

N = 19

N = 84

N = 20

N = 20

N = 22

N = 22

 Hemodiafiltration

3 (16)

18 (21)

3 (15)

3 (15)

6 (27)

6 (27)

 Hemodialysis

16 (84)

66 (79)

17 (85)

17 (85)

16 (73)

16 (73)

  1. BMI body mass index, Hgb hemoglobin, rhEPO recombinant human erythropoietin, ITT intention-to-treat, SD standard deviation
  2. aLow dose: < 100 IU/kg/week epoetin or < 0.5 μg/kg/week darbepoetin or < 0.6 μg/kg/week methoxy polyethylene glycol-epoetin beta
  3. bHigh dose: ≥100 IU/kg/week epoetin or ≥ 0.5 μg/kg/week darbepoetin or ≥ 0.6 μg/kg/week methoxy polyethylene glycol-epoetin beta
  4. cSafety population
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BMC Nephrology

ISSN: 1471-2369

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