Skip to main content

Table 2 Changes in iron- and erythrocyte-related parameters (safety-analysis set)

From: Effects of ferric citrate hydrate in patients with chronic kidney disease and heart failure: subgroup analysis of a long-term, real-world, post-marketing surveillance study

  

Time after treatment initiation

Baseline

4 weeks

12 weeks

24 weeks

36 weeks

52 weeks

76 weeks

104 weeks

Serum ferritin [ng/mL]

 Patients with heart failure

  HD

n

135

93

82

56

71

63

57

50

 

Absolute value, median (IQR)

44.50 (23.70, 94.60)

63.30 (35.40, 110.10)

83.45 (44.00, 122.00)

107.50 (81.55, 166.00)

115.00 (75.80, 187.00)

112.00 (71.30, 178.00)

121.80 (81.10, 187.00)

133.30 (81.80, 217.00)

 

n

 

80

75

50

59

56

46

40

 

Change from baseline, median (IQR)

 

7.05 (− 6.60, 26.75)

22.00 (4.00, 71.10)

52.70 (25.00, 97.00)

61.00 (30.90, 130.00)

66.10 (12.25, 107.05)

62.35 (25.00, 159.50)

71.45 (22.80, 157.80)

  PD

n

33

24

21

15

19

15

9

7

 

Absolute value, median (IQR)

146.00 (58.40, 223.60)

130.00 (67.00, 280.60)

194.00 (109.00, 266.00)

140.00 (87.00, 324.10)

219.20 (124.90, 366.00)

240.00 (174.00, 416.00)

306.00 (234.00, 351.00)

285.00 (264.20, 396.00)

 

n

 

24

20

13

17

13

8

6

 

Change from baseline, median (IQR)

 

14.00 (− 3.65, 63.05)

88.25 (30.75, 126.50)

84.00 (− 7.00, 116.40)

153.00 (93.40, 216.00)

187.00 (159.00, 206.30)

265.00 (190.60, 402.50)

219.50 (169.90, 273.00)

  ND

n

108

76

69

56

53

40

22

36

 

Absolute value, median (IQR)

91.00 (53.50, 122.30)

107.00 (63.65, 138.35)

124.50 (83.00, 176.90)

130.00 (92.00, 195.50)

138.00 (90.00, 200.00)

146.10 (91.25, 227.35)

165.50 (105.70, 220.00)

141.35 (75.20, 246.00)

 

n

 

63

62

47

47

37

16

31

 

Change from baseline, median (IQR)

 

13.00 (− 11.00, 29.40)

27.40 (6.00, 58.00)

44.00 (10.60, 97.00)

48.90 (9.80, 113.50)

57.60 (23.00, 157.20)

53.75 (45.45, 192.60)

62.00 (24.50, 187.10)

 Patients without heart failure

  HD

n

1079

658

702

557

650

622

538

504

 

Absolute value, median (IQR)

44.50 (21.10, 88.10)

57.95 (33.50, 111.00)

85.20 (46.00, 145.90)

114.00 (66.00, 183.00)

120.75 (71.40, 202.00)

124.00 (73.50, 202.20)

118.00 (69.00, 210.00)

122.65 (69.80, 231.60)

 

n

 

542

636

519

568

551

487

442

 

Change from baseline, median (IQR)

 

12.55 (− 3.20, 35.00)

26.90 (3.50, 67.00)

52.50 (13.80, 116.20)

63.00 (20.75, 130.25)

65.90 (18.00, 132.80)

61.00 (20.50, 139.50)

65.85 (15.20, 141.00)

  PD

n

139

90

81

72

73

68

53

41

 

Absolute value, median (IQR)

85.60 (51.00, 158.00)

100.30 (65.00, 163.10)

137.70 (67.70, 193.00)

162.95 (96.50, 284.50)

225.00 (130.70, 296.00)

216.00 (108.05, 345.00)

217.30 (146.00, 340.50)

259.00 (209.00, 415.20)

 

n

 

83

76

62

63

61

47

37

 

Change from baseline, median (IQR)

 

15.00 (− 4.00, 43.00)

34.25 (− 2.50, 85.90)

72.60 (27.00, 166.00)

99.00 (51.00, 192.00)

125.40 (51.60, 212.00)

132.10 (63.40, 271.00)

172.00 (112.70, 231.40)

  ND

n

490

328

271

192

208

156

110

85

 

Absolute value, median (IQR)

80.65 (41.00, 154.40)

108.50 (61.35, 181.50)

123.20 (75.00, 194.00)

155.00 (80.70, 217.20)

170.05 (95.60, 272.45)

178.40 (91.10, 262.00)

167.20 (88.70, 302.70)

196.80 (85.00, 292.00)

 

n

 

262

229

149

171

129

85

65

 

Change from baseline, median (IQR)

 

16.00 (− 2.00, 33.80)

30.30 (2.70, 66.90)

49.00 (21.60, 112.10)

87.00 (29.00, 157.00)

90.00 (31.00, 165.00)

98.20 (48.00, 205.6)

113.00 (50.00, 188.10)

TSAT [%]

 Patients with heart failure

  HD

n

128

96

78

50

67

62

52

43

 

Absolute value, mean (SD)

21.34 (13.30)

31.26 (16.58)

33.82 (16.68)

35.45 (14.17)

31.49 (11.28)

29.68 (12.04)

31.59 (15.21)

28.52 (13.53)

 

n

 

84

70

46

57

53

41

33

 

Change from baseline, mean (SD)

 

9.57 (16.38)

12.79 (15.29)

11.33 (16.67)

11.17 (14.71)

8.27 (15.39)

9.80 (16.11)

8.24 (17.36)

  PD

n

33

25

21

14

18

15

8

6

 

Absolute value, mean (SD)

28.47 (11.01)

31.62 (10.74)

37.96 (16.97)

35.88 (11.31)

41.41 (12.83)

40.99 (18.06)

41.89 (12.55)

39.40 (12.32)

 

n

 

25

20

13

17

14

7

5

 

Change from baseline, mean (SD)

 

4.16 (14.27)

9.55 (17.60)

4.92 (12.92)

15.01 (14.77)

16.55 (13.82)

21.64 (12.31)

19.10 (7.85)

  ND

n

96

66

61

50

49

38

21

35

 

Absolute value, mean (SD)

23.26 (13.55)

27.51 (14.87)

28.58 (13.99)

29.33 (11.73)

31.24 (12.26)

32.42 (11.02)

33.97 (12.81)

28.87 (11.75)

 

n

 

55

53

40

41

33

14

29

 

Change from baseline, mean (SD)

 

7.27 (14.71)

5.85 (13.90)

8.22 (13.05)

11.52 (12.32)

15.58 (11.25)

15.76 (12.49)

12.29 (12.02)

 Patients without heart failure

  HD

n

1100

697

737

587

686

653

554

513

 

Absolute value, mean (SD)

22.04 (11.95)

30.22 (13.84)

31.39 (13.10)

32.53 (13.63)

31.61 (11.89)

31.84 (12.85)

31.59 (13.00)

31.66 (13.32)

 

n

 

640

696

553

629

605

515

469

 

Change from baseline, mean (SD)

 

8.35 (15.01)

9.57 (14.96)

9.40 (16.01)

9.04 (14.13)

9.50 (15.18)

9.12 (14.68)

9.36 (15.80)

  PD

n

133

94

85

73

72

62

52

41

 

Absolute value, mean (SD)

30.76 (14.37)

35.72 (14.70)

35.02 (14.86)

37.51 (13.38)

39.50 (12.39)

36.78 (16.40)

41.01 (14.61)

36.92 (18.54)

 

n

 

87

78

65

62

55

47

36

 

Change from baseline, mean (SD)

 

5.37 (13.66)

4.96 (15.61)

7.68 (12.91)

9.67 (13.71)

7.85 (16.87)

12.28 (15.73)

8.19 (22.73)

  ND

n

426

284

230

166

177

127

96

80

 

Absolute value, mean (SD)

28.55 (12.08)

32.36 (12.74)

34.98 (13.05)

35.22 (15.17)

37.45 (15.12)

36.64 (15.50)

36.54 (15.74)

35.68 (14.25)

 

n

 

228

192

126

142

103

73

60

 

Change from baseline, mean (SD)

 

2.52 (12.75)

5.21 (13.16)

6.77 (13.91)

8.27 (15.50)

8.06 (14.39)

8.93 (17.26)

8.01 (15.59)

Serum iron [μg/dL]

 Patients with heart failure

  HD

n

133

101

82

50

69

63

52

46

 

Absolute value, mean (SD)

54.27 (29.50)

76.12 (37.89)

79.22 (34.39)

81.18 (30.22)

72.54 (25.60)

68.08 (24.80)

71.46 (28.76)

64.22 (26.87)

 

n

 

89

76

48

62

58

45

40

 

Change from baseline, mean (SD)

 

23.29 (43.42)

26.34 (35.78)

22.67 (33.48)

17.92 (33.55)

12.19 (32.16)

16.96 (35.16)

10.70 (32.55)

  PD

n

33

26

21

15

18

15

8

6

 

Absolute value, mean (SD)

72.55 (26.98)

78.50 (25.33)

92.48 (36.99)

97.53 (48.78)

105.56 (42.69)

102.13 (41.68)

99.00 (28.33)

88.33 (20.70)

 

n

 

26

20

13

17

14

7

5

 

Change from baseline, mean (SD)

 

7.12 (38.78)

18.90 (40.43)

14.23 (51.48)

36.82 (41.13)

36.00 (26.03)

38.86 (33.83)

33.00 (10.07)

  ND

n

107

71

64

53

52

40

22

36

 

Absolute value, mean (SD)

62.59 (33.44)

73.94 (38.07)

83.34 (35.33)

75.60 (20.16)

81.46 (26.46)

83.00 (29.24)

78.23 (33.47)

74.36 (25.95)

 

n

 

62

58

45

45

35

16

32

 

Change from baseline, mean (SD)

 

18.42 (41.51)

20.41 (38.13)

19.64 (31.15)

27.04 (30.52)

31.40 (38.88)

32.88 (36.70)

22.59 (34.60)

 Patients without heart failure

  HD

n

1176

780

806

628

733

697

586

540

 

Absolute value, mean (SD)

56.40 (27.36)

76.08 (37.65)

74.56 (30.88)

74.69 (30.63)

72.90 (28.32)

72.55 (30.30)

72.54 (31.69)

72.24 (36.90)

 

n

 

710

763

593

677

653

544

499

 

Change from baseline, mean (SD)

 

20.39 (38.22)

18.99 (34.83)

16.96 (37.05)

16.09 (34.09)

15.33 (35.84)

16.01 (37.40)

15.44 (42.28)

  PD

n

134

98

87

77

78

64

53

41

 

Absolute value, mean (SD)

76.69 (32.23)

90.53 (37.55)

86.72 (37.43)

89.36 (30.35)

89.54 (30.88)

84.17 (39.38)

92.49 (31.95)

81.29 (42.38)

 

n

 

92

80

71

68

56

47

35

 

Change from baseline, mean (SD)

 

13.15 (36.94)

9.71 (38.99)

14.61 (30.47)

15.21 (33.83)

11.48 (41.26)

20.55 (34.79)

8.09 (49.58)

  ND

n

472

313

255

185

203

147

109

90

 

Absolute value, mean (SD)

73.65 (31.92)

79.79 (29.95)

84.14 (29.38)

86.34 (33.74)

90.05 (35.07)

86.84 (33.98)

87.00 (34.17)

85.77 (33.02)

 

n

 

258

221

142

163

119

77

66

 

Change from baseline, mean (SD)

 

2.42 (36.99)

8.79 (32.04)

13.27 (36.64)

16.06 (40.93)

13.08 (34.70)

10.86 (38.46)

12.92 (39.73)

Hemoglobin [g/dL]

 Patients with heart failure

  HD

n

166

142

117

82

88

82

67

59

 

Absolute value, mean (SD)

10.60 (1.35)

10.99 (1.33)

11.60 (1.47)

11.07 (1.25)

11.28 (1.33)

11.32 (1.34)

11.15 (1.37)

11.16 (1.26)

 

n

 

142

117

82

88

82

67

59

 

Change from baseline, mean (SD)

 

0.38 (1.27)

0.88 (2.00)

0.21 (1.41)

0.56 (1.75)

0.57 (1.69)

0.44 (1.59)

0.47 (1.63)

  PD

n

36

32

28

17

22

18

12

9

 

Absolute value, mean (SD)

10.63 (1.39)

11.05 (1.33)

11.54 (1.19)

11.16 (0.75)

10.89 (0.96)

11.24 (1.41)

11.33 (1.06)

10.98 (1.16)

 

n

 

32

28

17

22

18

12

9

 

Change from baseline, mean (SD)

 

0.39 (1.31)

0.90 (1.86)

0.46 (1.10)

0.33 (1.49)

0.62 (1.66)

0.97 (1.74)

0.77 (1.58)

  ND

n

145

118

94

77

78

61

32

43

 

Absolute value, mean (SD)

10.24 (1.37)

10.78 (1.51)

11.15 (1.52)

11.19 (1.67)

11.13 (1.35)

11.35 (1.47)

11.33 (1.48)

11.13 (1.41)

 

n

 

118

94

76

77

61

32

43

 

Change from baseline, mean (SD)

 

0.44 (1.26)

0.83 (1.61)

0.72 (1.61)

0.64 (1.50)

0.80 (1.79)

0.99 (1.63)

0.60 (1.65)

 Patients without heart failure

  HD

n

1384

1115

1026

861

903

838

692

635

 

Absolute value, mean (SD)

10.68 (1.20)

11.21 (1.24)

11.50 (1.37)

11.19 (1.28)

11.18 (1.31)

11.20 (1.17)

11.13 (1.25)

11.21 (1.23)

 

n

 

1115

1021

855

898

831

688

630

 

Change from baseline, mean (SD)

 

0.52 (1.05)

0.81 (1.71)

0.48 (1.44)

0.46 (1.62)

0.47 (1.46)

0.38 (1.43)

0.47 (1.42)

  PD

n

164

138

116

93

99

84

66

55

 

Absolute value, mean (SD)

10.52 (1.24)

10.98 (1.23)

11.35 (1.50)

11.30 (1.42)

11.07 (1.26)

11.13 (1.30)

11.38 (1.27)

11.24 (1.29)

 

n

 

137

116

93

98

84

66

55

 

Change from baseline, mean (SD)

 

0.48 (1.17)

0.90 (1.57)

0.56 (1.57)

0.49 (1.35)

0.42 (1.50)

0.75 (1.59)

0.53 (1.58)

  ND

n

774

579

450

341

332

258

185

149

 

Absolute value, mean (SD)

10.39 (1.31)

10.72 (1.30)

11.02 (1.47)

10.96 (1.37)

11.05 (1.36)

11.15 (1.39)

11.33 (1.38)

11.49 (1.48)

 

n

 

579

449

340

331

257

185

 
 

Change from baseline, mean (SD)

 

0.33 (1.01)

0.55 (1.43)

0.50 (1.41)

0.61 (1.45)

0.52 (1.54)

0.66 (1.54)

0.77 (1.79)

  1. HD, hemodialysis group; PD, peritoneal dialysis group; ND, non-dialysis-dependent group; IQR, interquartile range (1st quartile, 3rd quartile); SD, standard deviation; TSAT, transferrin saturation