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Table 4 Changes in chronic kidney disease—mineral and bone disorder-related parameters (effectiveness-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 phosphate [mg/dL]

 Patients with heart failure

  HD

n

146

127

112

77

83

77

64

59

 

Absolute value, mean (SD)

6.73 (1.45)

5.69 (1.52)

5.34 (1.36)

5.16 (1.32)

5.19 (1.27)

5.09 (1.17)

5.04 (1.27)

5.09 (1.22)

 

n

 

127

112

77

83

77

64

59

 

Change from baseline, mean (SD)

 

 − 1.10 (1.38)

 − 1.36 (1.47)

 − 1.55 (1.51)

 − 1.40 (1.55)

 − 1.46 (1.56)

 − 1.55 (1.90)

 − 1.55 (1.62)

  PD

n

33

31

27

17

22

18

12

9

 

Absolute value, mean (SD)

6.62 (1.36)

5.96 (1.42)

5.53 (1.49)

5.21 (0.72)

5.62 (1.54)

5.71 (1.58)

5.03 (1.42)

5.34 (1.95)

   

31

27

17

22

18

12

9

 

Change from baseline, mean (SD)

 

 − 0.61 (1.13)

 − 1.09 (1.42)

 − 1.24 (1.31)

 − 1.03 (1.43)

 − 0.84 (1.15)

 − 1.47 (1.40)

 − 1.31 (1.13)

  ND

n

124

103

85

71

74

59

32

44

 

Absolute value, mean (SD)

5.33 (1.09)

4.92 (1.18)

4.74 (1.03)

4.60 (1.09)

4.74 (1.26)

4.79 (1.13)

4.91 (1.25)

4.70 (1.05)

 

n

 

103

85

71

74

59

32

44

 

Change from baseline, mean (SD)

 

 − 0.44 (1.00)

 − 0.49 (0.91)

 − 0.49 (1.26)

 − 0.34 (1.24)

 − 0.22 (1.16)

 − 0.07 (1.34)

 − 0.23 (1.09)

 Patients without heart failure

  HD

n

1223

1012

945

810

850

798

674

631

 

Absolute value, mean (SD)

6.56 (1.38)

5.82 (1.45)

5.57 (1.45)

5.31 (1.35)

5.39 (1.41)

5.35 (1.34)

5.43 (1.27)

5.40 (1.31)

 

n

 

1011

940

806

847

793

671

627

 

Change from baseline, mean (SD)

 

 − 0.76 (1.48)

 − 0.96 (1.54)

 − 1.17 (1.61)

 − 1.14 (1.70)

 − 1.18 (1.63)

 − 1.13 (1.62)

 − 1.17 (1.62)

  PD

n

144

125

106

88

89

77

63

53

 

Absolute value, mean (SD)

6.06 (1.35)

5.51 (1.16)

5.39 (1.43)

5.42 (1.52)

5.27 (1.17)

5.27 (1.02)

5.26 (1.10)

5.10 (1.16)

 

n

 

125

106

88

89

77

63

53

 

Change from baseline, mean (SD)

 

 − 0.58 (1.32)

 − 0.72 (1.40)

 − 0.74 (1.53)

 − 0.69 (1.46)

 − 0.77 (1.48)

 − 0.80 (1.49)

 − 1.06 (1.72)

  ND

n

657

499

399

308

312

249

181

149

 

Absolute value, mean (SD)

5.34 (1.03)

4.95 (1.13)

4.78 (1.12)

4.84 (1.21)

4.90 (1.26)

4.82 (1.22)

4.88 (1.27)

4.90 (1.19)

 

n

 

499

398

307

312

248

181

149

 

Change from baseline, mean (SD)

 

 − 0.44 (0.99)

 − 0.51 (1.10)

 − 0.37(1.16)

 − 0.23 (1.27)

 − 0.27 (1.19)

 − 0.16 (1.22)

 − 0.16 (1.22)

Corrected Ca [mg/dL]

 Patients with heart failure

  HD

n

146

127

112

77

83

77

64

59

 

Absolute value, mean (SD)

8.55 (0.77)

8.66 (0.68)

8.68 (0.75)

8.65 (0.73)

8.57 (0.79)

8.69 (0.64)

8.64 (0.66)

8.66 (0.72)

 

n

 

127

112

77

83

77

64

59

 

Change from baseline, mean (SD)

 

0.12 (0.63)

0.14 (0.78)

0.10 (0.81)

0.02 (0.91)

0.23 (0.80)

0.14 (0.81)

0.15 (0.75)

  PD

n

33

31

27

17

22

18

12

9

 

Absolute value, mean (SD)

8.25 (0.80)

8.37 (0.66)

8.61 (0.66)

8.49 (0.67)

8.54 (0.70)

8.23 (0.73)

8.51 (0.86)

8.46 (0.68)

 

n

 

31

27

17

22

18

12

9

 

Change from baseline, mean (SD)

 

0.05 (0.65)

0.25 (0.70)

0.09 (0.87)

0.20 (0.96)

 − 0.25 (0.88)

0.27 (1.22)

0.17 (1.21)

  ND

n

122

103

84

70

73

59

32

44

 

Absolute value, mean (SD)

8.38 (0.69)

8.49 (0.69)

8.57 (0.67)

8.49 (0.74)

8.48 (0.72)

8.61 (0.81)

8.72 (0.61)

8.63 (0.72)

 

n

 

102

84

69

72

59

32

44

 

Change from baseline, mean (SD)

 

0.12 (0.46)

0.16 (0.53)

0.04 (0.62)

 − 0.02(0.60)

0.13 (0.70)

0.25 (0.67)

0.02 (0.70)

 Patients without heart failure

  HD

n

1222

1010

943

809

850

798

672

631

 

Absolute value, mean (SD)

8.73 (0.81)

8.76 (0.75)

8.78 (0.72)

8.80 (0.70)

8.76 (0.75)

8.77 (0.73)

8.75 (0.67)

8.74 (0.70)

 

n

 

1009

938

806

847

793

669

627

 

Change from baseline, mean (SD)

 

0.04 (0.68)

0.09 (0.74)

0.11 (0.85)

0.05 (0.90)

0.07 (0.86)

0.05 (0.90)

0.01 (0.90)

  PD

n

142

123

106

88

89

77

63

55

 

Absolute value, mean (SD)

8.5 (0.78)

8.57 (0.67)

8.54 (0.69)

8.59 (0.78)

8.6 (0.72)

8.64 (0.77)

8.54 (0.63)

8.55 (0.73)

 

n

 

123

106

88

88

77

63

55

 

Change from baseline, mean (SD)

 

0.10 (0.55)

0.04 (0.67)

0.09 (0.81)

0.09 (0.85)

0.14 (0.91)

 − 0.03 (0.85)

0.00 (1.02)

  ND

n

656

500

399

309

312

249

181

148

 

Absolute value, mean (SD)

8.56 (0.80)

8.60 (0.77)

8.62 (0.96)

8.62 (0.72)

8.66 (0.79)

8.75 (0.68)

8.73 (0.77)

8.78 (0.71)

 

n

 

499

398

307

312

248

181

148

 

Change from baseline, mean (SD)

 

0.05 (0.60)

0.04 (0.79)

 − 0.01 (0.68)

 − 0.01 (0.75)

0.02 (0.70)

 − 0.05 (0.91)

0.02 (0.92)

Intact PTH [pg/mL]

 Patients with heart failure

  HD

n

104

66

70

44

57

54

51

44

 

Absolute value, median (IQR)

158.00 (99.00, 269.50)

149.50 (98.00, 238.00)

134.00 (77.00, 216.00)

179.50 (90.50, 258.00)

142.00 (70.00, 237.00)

136.50 (86.00, 214.00)

119.00 (79.00, 206.00)

108.50 (66.50, 177.00)

 

n

 

54

63

40

51

48

42

37

 

Change from baseline, median (IQR)

 

 − 17.00 (− 69.00, 1.00)

 − 22.00 (− 82.00, 14.00)

 − 1.00 (− 56.50, 77.50)

 − 12.00 (− 127.00, 40.00)

 − 17.00 (− 116.00, 27.50)

 − 15.00 (− 94.00, 43.00)

 − 26.00 (− 104.00, 17.00)

  PD

n

26

22

19

15

17

15

11

8

 

Absolute value, median (IQR)

171.00 (110.00, 339.00)

199.50 (89.00, 313.00)

163.00 (59.00, 228.00)

107.00 (52.00, 284.00)

194.00 (87.00, 259.00)

194.00 (89.00, 231.00)

137.00 (114.00, 230.00)

164.50 (122.00, 194.50)

 

n

 

20

18

13

16

14

9

6

 

Change from baseline, median (IQR)

 

 − 12.00 (− 61.00, 30.00)

 − 34.00 (− 136.00, 5.00)

0.00 (− 25.00, 11.00)

 − 12.00 (− 171.00, 53.50)

 − 9.00 (− 89.00, 37.00)

 − 13.00 (− 315.00, 4.00)

29.50 (− 79.00, 73.00)

  ND

n

63

41

46

44

46

38

17

32

 

Absolute value, median (SD)

194.00 (106.00, 296.00)

194.00 (112.00, 265.00)

148.00 (106.00, 219.00)

157.00 (105.50, 256.50)

187.50 (122.00, 290.00)

148.00 (85.00, 229.00)

162.00 (96.00, 198.00)

167.00 (99.50, 222.00)

 

n

 

30

40

31

32

26

7

22

 

Change from baseline, median (IQR)

 

 − 11.50 (− 85.00, 30.00)

 − 14.50 (− 47.50, 7.00)

 − 26.00 (− 76.00, 14.00)

 − 24.00 (− 57.00, 29.00)

 − 5.50 (− 59.00, 32.00)

 − 66.00 (− 89.00, − 10.00)

20.50 (− 5.00, 39.00)

 Patients without heart failure

  HD

n

878

555

579

480

544

552

512

487

 

Absolute value, median (IQR)

177.00 (106.00, 267.00)

163.00 (95.00, 245.00)

150.00 (92.00, 237.00)

144.00 (85.50, 214.00)

145.00 (92.50, 218.50)

145.50 (97.00, 222.50)

158.00 (92.00, 233.00)

154.00 (90.00, 220.00)

 

n

 

465

525

439

473

482

442

416

 

Change from baseline, median (IQR)

 

 − 10.00 (− 58.00, 25.00)

 − 13.00 (− 66.00, 29.00)

 − 15.00 (− 81.00, 38.00)

 − 12.00 (− 95.00, 40.00)

 − 13.00 (− 88.00, 38.00)

 − 9.50 (− 97.00, 45.00)

 − 11.50 (− 105.00, 50.50)

  PD

n

94

67

61

61

51

48

42

38

 

Absolute value, median (IQR)

193.50 (102.00, 371.00)

186.00 (86.00, 294.00)

177.00 (91.00, 318.00)

199.00 (102.00, 341.00)

167.00 (83.00, 249.00)

164.00 (80.00, 277.5)

195.00 (91.00, 329.00)

143.00 (83.00, 213.00)

 

n

 

62

54

53

41

41

34

31

 

Change from baseline, median (IQR)

 

 − 7.00 (− 60.00, 29.00)

9.00 (− 69.00, 52.00)

13.00 (− 90.00, 86.00)

2.00 (− 129.00, 90.00)

 − 1.00 (− 118.00, 94.00)

5.00 (− 169.00, 145.00)

 − 18.0 (− 234.00, 106.00)

  ND

n

261

167

148

127

135

106

86

71

 

Absolute value, median (SD)

228.00 (117.00, 373.00)

215.00 (121.00, 350.00)

210.00 (116.00, 337.50)

233.00 (122.00, 363.00)

211.00 (101.00, 367.00)

201.00 (100.00, 330.00)

193.50 (114.00, 295.00)

154.00 (98.00, 290.00)

 

n

 

119

109

84

79

63

45

40

 

Change from baseline, median (IQR)

 

 − 8.00 (− 38.00, 31.00)

4.00 (− 44.00, 38.00)

18.00 (− 42.00, 58.00)

1.00 (− 43.00, 47.00)

14.00 (− 42.00, 76.00)

6.00 (− 56.00, 63.00)

 − 7.00 (− 92.00, 56.00)

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