Table 1. Open in new tab Patient...

Characteristics	Placebo (n = 28)	0.7 mg/kg	1.0 mg/kg	1.5 mg/kg	2.0 mg/kg	Pooled roxadustat (n = 88)	Total (N = 116)
Sex, n (%)
Male	16 (57.1)	6 (60.0)	6 (46.2)	4 (33.3)	6 (66.7)	4 (40.0)	1 (9.1)	3 (27.3)	3 (25.0)	33 (37.5)	49 (42.2)
Female	12 (42.9)	4 (40.0)	7 (53.8)	8 (66.7)	3 (33.3)	6 (60.0)	10 (90.9)	8 (72.7)	9 (75.0)	55 (62.5)	67 (57.8)
Race, n (%)
White	15 (53.6)	4 (40.0)	9 (69.2)	6 (50.0)	5 (55.6)	7 (70.0)	4 (36.4)	8 (72.7)	6 (50.0)	49 (55.7)	64 (55.2)
Black	11 (39.3)	6 (60.0)	4 (30.8)	3 (25.0)	3 (33.3)	3 (30.0)	7 (63.5)	3 (27.3)	5 (41.7)	34 (38.6)	45 (38.8)
Asian	2 (7.1)	0	0	1 (8.3)	0	0	0	0	1 (8.3)	2 (2.3)	4 (3.4)
Other	0	0	0	2 (16.7)	1 (11.1)	0	0	0	0	3 (3.4)	3 (2.6)
Age in years
Mean	68.6	64.6	60.6	69.5	67.0	63.8	63.5	64.3	66.8	64.0	65.8
Range	56–79	57–73	47–75	52–80	54–79	52–77	49–72	53–82	49–76	47–82	47–82
eGFR (mL/min/1.73 m²), mean (SD)	31.4 (12.4)	32.1 (14.2)	33.0 (11.1)	38.0 (15.5)	35.2 (9.7)	27.9 (8.2)	40.1 (15.3)	34.7 (15.1)	32.7 (9.9)	34.3 (12.7)	33.6 (12.6)
Hb (g/dL),mean (SD)	10.3 (0.9)	10.3 (0.7)	9.9 (0.8)	10.4 (1.5)	10.6 (0.9)	10.3 (0.6)	10.1 (0.7)	10.3 (1.0)	10.1 (1.1)	10.3 (0.9)	10.3 (0.9)
TSAT (%), mean (SD)	28.3 (6.8)	30.1 (6.4)	30.1 (11.3)	24.0 (9.4)	23.5 (5.2)	31.1 (8.1)	25.8 (6.5)	30.0 (9.3)	31.6 (11.0)	28.4 (9.0)	28.4 (8.5)
>20%, n (%)	26 (92.9)	10 (100)	12 (92.3)	8 (66.7)	7 (77.8)	9 (90.0)	9 (81.8)	11 (100)	11 (91.7)	77 (87.5)	103 (88.8)
≤20%, n (%)	2 (7.1)	0	1 (7.7)	4 (33.3)	2 (22.2)	1 (10)	2 (18.2)	0	1 (8.3)	11 (12.5)	13 (11.2)
Ferritin (ng/mL), mean (SD)	228 (193)	164 (68.1)	231 (143)	174 (181)	167 (178)	228 (184)	184 (101)	242 (218)	190 (89.4)	199 (150)	206 (161)
>100 ng/mL, n (%)	21 (75.0)	7 (70.0)	13 (100)	8 (66.7)	4 (44.4)	9 (90.0)	11 (100)	6 (54.5)	10 (83.3)	68 (77.3)	89 (76.7)
≤100, ng/mL n (%)	7 (25.0)	3 (30.0)	0	4 (33.3)	5 (55.6)	1 (10.0)	0	5 (45.5)	2 (16.7)	20 (22.7)	27 (23.3)
Cuff BP (mmHg), mean (SD)	92.4 (10.5)	93.3 (7.0)	93.7 (12.1)	90.5 (13.2)	96.6 (14.8)	92.5 (14.2)	91.0 (7.0)	88.6 (7.7)	88.7 (5.4)	91.7 (10.7)	91.9 (10.6)

Characteristics

Placebo (n = 28)

0.7 mg/kg

1.0 mg/kg

1.5 mg/kg

2.0 mg/kg

Pooled roxadustat (n = 88)

Total (N = 116)

BIW (n = 10)

TIW (n = 13)

BIW (n = 12)

TIW (n = 9)

BIW (n = 10)

TIW (n = 11)

BIW (n = 11)

TIW (n = 12)

Sex, n (%)

Male

16 (57.1)

6 (60.0)

6 (46.2)

4 (33.3)

6 (66.7)

4 (40.0)

1 (9.1)

3 (27.3)

3 (25.0)

33 (37.5)

49 (42.2)

Female

12 (42.9)

4 (40.0)

7 (53.8)

8 (66.7)

3 (33.3)

6 (60.0)

10 (90.9)

8 (72.7)

9 (75.0)

55 (62.5)

67 (57.8)

Race, n (%)

White

15 (53.6)

4 (40.0)

9 (69.2)

6 (50.0)

5 (55.6)

7 (70.0)

4 (36.4)

8 (72.7)

6 (50.0)

49 (55.7)

64 (55.2)

Black

11 (39.3)

6 (60.0)

4 (30.8)

3 (25.0)

3 (33.3)

3 (30.0)

7 (63.5)

3 (27.3)

5 (41.7)

34 (38.6)

45 (38.8)

Asian

2 (7.1)

1 (8.3)

2 (2.3)

4 (3.4)

Other

2 (16.7)

1 (11.1)

3 (3.4)

3 (2.6)

Age in years

Mean

68.6

64.6

60.6

69.5

67.0

63.8

63.5

64.3

66.8

64.0

65.8

Range

56–79

57–73

47–75

52–80

54–79

52–77

49–72

53–82

49–76

47–82

eGFR (mL/min/1.73 m²), mean (SD)

31.4 (12.4)

32.1 (14.2)

33.0 (11.1)

38.0 (15.5)

35.2 (9.7)

27.9 (8.2)

40.1 (15.3)

34.7 (15.1)

32.7 (9.9)

34.3 (12.7)

33.6 (12.6)

Hb (g/dL),mean (SD)

10.3 (0.9)

10.3 (0.7)

9.9 (0.8)

10.4 (1.5)

10.6 (0.9)

10.3 (0.6)

10.1 (0.7)

10.3 (1.0)

10.1 (1.1)

10.3 (0.9)

TSAT (%), mean (SD)

28.3 (6.8)

30.1 (6.4)

30.1 (11.3)

24.0 (9.4)

23.5 (5.2)

31.1 (8.1)

25.8 (6.5)

30.0 (9.3)

31.6 (11.0)

28.4 (9.0)

28.4 (8.5)

>20%, n (%)

26 (92.9)

10 (100)

12 (92.3)

8 (66.7)

7 (77.8)

9 (90.0)

9 (81.8)

11 (100)

11 (91.7)

77 (87.5)

103 (88.8)

≤20%, n (%)

2 (7.1)

1 (7.7)

4 (33.3)

2 (22.2)

1 (10)

2 (18.2)

1 (8.3)

11 (12.5)

13 (11.2)

Ferritin (ng/mL), mean (SD)

228 (193)

164 (68.1)

231 (143)

174 (181)

167 (178)

228 (184)

184 (101)

242 (218)

190 (89.4)

199 (150)

206 (161)

>100 ng/mL, n (%)

21 (75.0)

7 (70.0)

13 (100)

8 (66.7)

4 (44.4)

9 (90.0)

11 (100)

6 (54.5)

10 (83.3)

68 (77.3)

89 (76.7)

≤100, ng/mL n (%)

7 (25.0)

3 (30.0)

4 (33.3)

5 (55.6)

1 (10.0)

5 (45.5)

2 (16.7)

20 (22.7)

27 (23.3)

Cuff BP (mmHg), mean (SD)

92.4 (10.5)

93.3 (7.0)

93.7 (12.1)

90.5 (13.2)

96.6 (14.8)

92.5 (14.2)

91.0 (7.0)

88.6 (7.7)

88.7 (5.4)

91.7 (10.7)

91.9 (10.6)

Characteristics	Placebo (n = 28)	0.7 mg/kg	1.0 mg/kg	1.5 mg/kg	2.0 mg/kg	Pooled roxadustat (n = 88)	Total (N = 116)
Sex, n (%)
Male	16 (57.1)	6 (60.0)	6 (46.2)	4 (33.3)	6 (66.7)	4 (40.0)	1 (9.1)	3 (27.3)	3 (25.0)	33 (37.5)	49 (42.2)
Female	12 (42.9)	4 (40.0)	7 (53.8)	8 (66.7)	3 (33.3)	6 (60.0)	10 (90.9)	8 (72.7)	9 (75.0)	55 (62.5)	67 (57.8)
Race, n (%)
White	15 (53.6)	4 (40.0)	9 (69.2)	6 (50.0)	5 (55.6)	7 (70.0)	4 (36.4)	8 (72.7)	6 (50.0)	49 (55.7)	64 (55.2)
Black	11 (39.3)	6 (60.0)	4 (30.8)	3 (25.0)	3 (33.3)	3 (30.0)	7 (63.5)	3 (27.3)	5 (41.7)	34 (38.6)	45 (38.8)
Asian	2 (7.1)	0	0	1 (8.3)	0	0	0	0	1 (8.3)	2 (2.3)	4 (3.4)
Other	0	0	0	2 (16.7)	1 (11.1)	0	0	0	0	3 (3.4)	3 (2.6)
Age in years
Mean	68.6	64.6	60.6	69.5	67.0	63.8	63.5	64.3	66.8	64.0	65.8
Range	56–79	57–73	47–75	52–80	54–79	52–77	49–72	53–82	49–76	47–82	47–82
eGFR (mL/min/1.73 m²), mean (SD)	31.4 (12.4)	32.1 (14.2)	33.0 (11.1)	38.0 (15.5)	35.2 (9.7)	27.9 (8.2)	40.1 (15.3)	34.7 (15.1)	32.7 (9.9)	34.3 (12.7)	33.6 (12.6)
Hb (g/dL),mean (SD)	10.3 (0.9)	10.3 (0.7)	9.9 (0.8)	10.4 (1.5)	10.6 (0.9)	10.3 (0.6)	10.1 (0.7)	10.3 (1.0)	10.1 (1.1)	10.3 (0.9)	10.3 (0.9)
TSAT (%), mean (SD)	28.3 (6.8)	30.1 (6.4)	30.1 (11.3)	24.0 (9.4)	23.5 (5.2)	31.1 (8.1)	25.8 (6.5)	30.0 (9.3)	31.6 (11.0)	28.4 (9.0)	28.4 (8.5)
>20%, n (%)	26 (92.9)	10 (100)	12 (92.3)	8 (66.7)	7 (77.8)	9 (90.0)	9 (81.8)	11 (100)	11 (91.7)	77 (87.5)	103 (88.8)
≤20%, n (%)	2 (7.1)	0	1 (7.7)	4 (33.3)	2 (22.2)	1 (10)	2 (18.2)	0	1 (8.3)	11 (12.5)	13 (11.2)
Ferritin (ng/mL), mean (SD)	228 (193)	164 (68.1)	231 (143)	174 (181)	167 (178)	228 (184)	184 (101)	242 (218)	190 (89.4)	199 (150)	206 (161)
>100 ng/mL, n (%)	21 (75.0)	7 (70.0)	13 (100)	8 (66.7)	4 (44.4)	9 (90.0)	11 (100)	6 (54.5)	10 (83.3)	68 (77.3)	89 (76.7)
≤100, ng/mL n (%)	7 (25.0)	3 (30.0)	0	4 (33.3)	5 (55.6)	1 (10.0)	0	5 (45.5)	2 (16.7)	20 (22.7)	27 (23.3)
Cuff BP (mmHg), mean (SD)	92.4 (10.5)	93.3 (7.0)	93.7 (12.1)	90.5 (13.2)	96.6 (14.8)	92.5 (14.2)	91.0 (7.0)	88.6 (7.7)	88.7 (5.4)	91.7 (10.7)	91.9 (10.6)

Table 1.

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Patient demographics and BL characteristics (safety population)

Characteristics	Placebo (n = 28)	0.7 mg/kg		1.0 mg/kg		1.5 mg/kg		2.0 mg/kg		Pooled roxadustat (n = 88)	Total (N = 116)
Characteristics	Placebo (n = 28)	BIW (n = 10)	TIW (n = 13)	BIW (n = 12)	TIW (n = 9)	BIW (n = 10)	TIW (n = 11)	BIW (n = 11)	TIW (n = 12)	Pooled roxadustat (n = 88)	Total (N = 116)
Sex, n (%)
Male	16 (57.1)	6 (60.0)	6 (46.2)	4 (33.3)	6 (66.7)	4 (40.0)	1 (9.1)	3 (27.3)	3 (25.0)	33 (37.5)	49 (42.2)
Female	12 (42.9)	4 (40.0)	7 (53.8)	8 (66.7)	3 (33.3)	6 (60.0)	10 (90.9)	8 (72.7)	9 (75.0)	55 (62.5)	67 (57.8)
Race, n (%)
White	15 (53.6)	4 (40.0)	9 (69.2)	6 (50.0)	5 (55.6)	7 (70.0)	4 (36.4)	8 (72.7)	6 (50.0)	49 (55.7)	64 (55.2)
Black	11 (39.3)	6 (60.0)	4 (30.8)	3 (25.0)	3 (33.3)	3 (30.0)	7 (63.5)	3 (27.3)	5 (41.7)	34 (38.6)	45 (38.8)
Asian	2 (7.1)	0	0	1 (8.3)	0	0	0	0	1 (8.3)	2 (2.3)	4 (3.4)
Other	0	0	0	2 (16.7)	1 (11.1)	0	0	0	0	3 (3.4)	3 (2.6)
Age in years
Mean	68.6	64.6	60.6	69.5	67.0	63.8	63.5	64.3	66.8	64.0	65.8
Range	56–79	57–73	47–75	52–80	54–79	52–77	49–72	53–82	49–76	47–82	47–82
eGFR (mL/min/1.73 m²), mean (SD)	31.4 (12.4)	32.1 (14.2)	33.0 (11.1)	38.0 (15.5)	35.2 (9.7)	27.9 (8.2)	40.1 (15.3)	34.7 (15.1)	32.7 (9.9)	34.3 (12.7)	33.6 (12.6)
Hb (g/dL),mean (SD)	10.3 (0.9)	10.3 (0.7)	9.9 (0.8)	10.4 (1.5)	10.6 (0.9)	10.3 (0.6)	10.1 (0.7)	10.3 (1.0)	10.1 (1.1)	10.3 (0.9)	10.3 (0.9)
TSAT (%), mean (SD)	28.3 (6.8)	30.1 (6.4)	30.1 (11.3)	24.0 (9.4)	23.5 (5.2)	31.1 (8.1)	25.8 (6.5)	30.0 (9.3)	31.6 (11.0)	28.4 (9.0)	28.4 (8.5)
>20%, n (%)	26 (92.9)	10 (100)	12 (92.3)	8 (66.7)	7 (77.8)	9 (90.0)	9 (81.8)	11 (100)	11 (91.7)	77 (87.5)	103 (88.8)
≤20%, n (%)	2 (7.1)	0	1 (7.7)	4 (33.3)	2 (22.2)	1 (10)	2 (18.2)	0	1 (8.3)	11 (12.5)	13 (11.2)
Ferritin (ng/mL), mean (SD)	228 (193)	164 (68.1)	231 (143)	174 (181)	167 (178)	228 (184)	184 (101)	242 (218)	190 (89.4)	199 (150)	206 (161)
>100 ng/mL, n (%)	21 (75.0)	7 (70.0)	13 (100)	8 (66.7)	4 (44.4)	9 (90.0)	11 (100)	6 (54.5)	10 (83.3)	68 (77.3)	89 (76.7)
≤100, ng/mL n (%)	7 (25.0)	3 (30.0)	0	4 (33.3)	5 (55.6)	1 (10.0)	0	5 (45.5)	2 (16.7)	20 (22.7)	27 (23.3)
Cuff BP (mmHg), mean (SD)	92.4 (10.5)	93.3 (7.0)	93.7 (12.1)	90.5 (13.2)	96.6 (14.8)	92.5 (14.2)	91.0 (7.0)	88.6 (7.7)	88.7 (5.4)	91.7 (10.7)	91.9 (10.6)

Characteristics	Placebo (n = 28)	0.7 mg/kg		1.0 mg/kg		1.5 mg/kg		2.0 mg/kg		Pooled roxadustat (n = 88)	Total (N = 116)
Characteristics	Placebo (n = 28)	BIW (n = 10)	TIW (n = 13)	BIW (n = 12)	TIW (n = 9)	BIW (n = 10)	TIW (n = 11)	BIW (n = 11)	TIW (n = 12)	Pooled roxadustat (n = 88)	Total (N = 116)
Sex, n (%)
Male	16 (57.1)	6 (60.0)	6 (46.2)	4 (33.3)	6 (66.7)	4 (40.0)	1 (9.1)	3 (27.3)	3 (25.0)	33 (37.5)	49 (42.2)
Female	12 (42.9)	4 (40.0)	7 (53.8)	8 (66.7)	3 (33.3)	6 (60.0)	10 (90.9)	8 (72.7)	9 (75.0)	55 (62.5)	67 (57.8)
Race, n (%)
White	15 (53.6)	4 (40.0)	9 (69.2)	6 (50.0)	5 (55.6)	7 (70.0)	4 (36.4)	8 (72.7)	6 (50.0)	49 (55.7)	64 (55.2)
Black	11 (39.3)	6 (60.0)	4 (30.8)	3 (25.0)	3 (33.3)	3 (30.0)	7 (63.5)	3 (27.3)	5 (41.7)	34 (38.6)	45 (38.8)
Asian	2 (7.1)	0	0	1 (8.3)	0	0	0	0	1 (8.3)	2 (2.3)	4 (3.4)
Other	0	0	0	2 (16.7)	1 (11.1)	0	0	0	0	3 (3.4)	3 (2.6)
Age in years
Mean	68.6	64.6	60.6	69.5	67.0	63.8	63.5	64.3	66.8	64.0	65.8
Range	56–79	57–73	47–75	52–80	54–79	52–77	49–72	53–82	49–76	47–82	47–82
eGFR (mL/min/1.73 m²), mean (SD)	31.4 (12.4)	32.1 (14.2)	33.0 (11.1)	38.0 (15.5)	35.2 (9.7)	27.9 (8.2)	40.1 (15.3)	34.7 (15.1)	32.7 (9.9)	34.3 (12.7)	33.6 (12.6)
Hb (g/dL),mean (SD)	10.3 (0.9)	10.3 (0.7)	9.9 (0.8)	10.4 (1.5)	10.6 (0.9)	10.3 (0.6)	10.1 (0.7)	10.3 (1.0)	10.1 (1.1)	10.3 (0.9)	10.3 (0.9)
TSAT (%), mean (SD)	28.3 (6.8)	30.1 (6.4)	30.1 (11.3)	24.0 (9.4)	23.5 (5.2)	31.1 (8.1)	25.8 (6.5)	30.0 (9.3)	31.6 (11.0)	28.4 (9.0)	28.4 (8.5)
>20%, n (%)	26 (92.9)	10 (100)	12 (92.3)	8 (66.7)	7 (77.8)	9 (90.0)	9 (81.8)	11 (100)	11 (91.7)	77 (87.5)	103 (88.8)
≤20%, n (%)	2 (7.1)	0	1 (7.7)	4 (33.3)	2 (22.2)	1 (10)	2 (18.2)	0	1 (8.3)	11 (12.5)	13 (11.2)
Ferritin (ng/mL), mean (SD)	228 (193)	164 (68.1)	231 (143)	174 (181)	167 (178)	228 (184)	184 (101)	242 (218)	190 (89.4)	199 (150)	206 (161)
>100 ng/mL, n (%)	21 (75.0)	7 (70.0)	13 (100)	8 (66.7)	4 (44.4)	9 (90.0)	11 (100)	6 (54.5)	10 (83.3)	68 (77.3)	89 (76.7)
≤100, ng/mL n (%)	7 (25.0)	3 (30.0)	0	4 (33.3)	5 (55.6)	1 (10.0)	0	5 (45.5)	2 (16.7)	20 (22.7)	27 (23.3)
Cuff BP (mmHg), mean (SD)	92.4 (10.5)	93.3 (7.0)	93.7 (12.1)	90.5 (13.2)	96.6 (14.8)	92.5 (14.2)	91.0 (7.0)	88.6 (7.7)	88.7 (5.4)	91.7 (10.7)	91.9 (10.6)

eGFR, estimated glomerular filtration rated (MDRD formula); Hb, hemoglobin; TSAT, transferrin saturation.

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