. 2022 Jul 11;55(1):141–150. doi: 10.1007/s11255-022-03287-1

Table 2.

Changes in mineral and bone disorder-related parameters in non-dialysis-dependent patients from the GBA4-4 study (efficacy analysis set)

Mean (SD)	FC, n = 57	Placebo, n = 29	FC − Placebo^a
Serum P [mg/dL]	5.53 (0.59)	4.43 (1.57)	− 1.10 (1.20)	5.70 (0.80)	4.35 (1.18)	− 1.35 (1.31)	5.28 (0.64)	5.15 (0.85)	− 0.13 (0.65)	5.81 (0.52)	6.01 (0.73)	0.21 (0.67)	− 0.85 (− 1.70, − 0.01)	− 1.61 (− 2.23, − 0.98)	0.16
Serum cCa [mg/dL]	8.74 (0.64)	8.96 (0.41)	0.22 (0.54)	8.58 (0.48)	8.78 (0.61)	0.20 (0.51)	8.61 (0.45)	8.67 (0.34)	0.06 (0.31)	8.54 (0.44)	8.48 (0.48)	− 0.06 (0.40)	0.21 (− 0.13, 0.55)	0.27 (0.02, 0.53)	0.77
iPTH [pg/mL]	317.2 (478.8)	273.1 (359.5)	− 44.1 (135.1)	321.0 (260.1)	251.1 (179.6)	− 70.0 (134.4)	223.2 (129.2)	203.5 (139.0)	− 19.7 (71.2)	312.3 (202.6)	361.0 (280.7)	48.7 (125.1)	0.4 (− 79.5, 80.3)	− 116.3 (− 175.5, − 57.2)	0.02
Ca*P [(mg/dL)²]	48.35 (6.43)	39.66 (13.82)	− 8.69 (10.53)	48.86 (7.11)	37.86 (9.17)	− 11.0 (10.56)	45.39 (5.66)	44.51 (6.66)	− 0.88 (5.28)	49.54 (4.26)	50.87 (5.67)	1.34 (4.87)	− 6.37 (− 13.17, 0.43)	− 12.66 (− 17.68, − 7.64)	0.14

Mean (SD)

FC, n = 57

Placebo, n = 29

FC − Placebo^a

With GASI, n = 13

Without GASI, n = 44

With GASI, n = 13

Without GASI, n = 16

With GASI

Without GASI

Interaction

EOT

Change

EOT

Change

EOT

Change

EOT

Change

FC − placebo, adjusted mean difference^b (95% CI)

P value^c

Serum P [mg/dL]

5.53

(0.59)

4.43

(1.57)

− 1.10

(1.20)

5.70

(0.80)

4.35

(1.18)

− 1.35

(1.31)

5.28

(0.64)

5.15

(0.85)

− 0.13

(0.65)

5.81

(0.52)

6.01

(0.73)

0.21

(0.67)

− 0.85

(− 1.70, − 0.01)

− 1.61

(− 2.23, − 0.98)

0.16

Serum cCa [mg/dL]

8.74

(0.64)

8.96

(0.41)

0.22

(0.54)

8.58

(0.48)

8.78

(0.61)

0.20

(0.51)

8.61

(0.45)

8.67

(0.34)

0.06

(0.31)

8.54

(0.44)

8.48

(0.48)

− 0.06

(0.40)

0.21

(− 0.13, 0.55)

0.27

(0.02, 0.53)

0.77

iPTH

[pg/mL]

317.2

(478.8)

273.1

(359.5)

− 44.1

(135.1)

321.0

(260.1)

251.1

(179.6)

− 70.0

(134.4)

223.2

(129.2)

203.5

(139.0)

− 19.7

(71.2)

312.3

(202.6)

361.0

(280.7)

48.7

(125.1)

0.4

(− 79.5, 80.3)

− 116.3

(− 175.5, − 57.2)

0.02

Ca*P [(mg/dL)²]

48.35

(6.43)

39.66

(13.82)

− 8.69

(10.53)

48.86

(7.11)

37.86

(9.17)

− 11.0

(10.56)

45.39

(5.66)

44.51

(6.66)

− 0.88

(5.28)

49.54

(4.26)

50.87

(5.67)

1.34

(4.87)

− 6.37

(− 13.17, 0.43)

− 12.66

(− 17.68, − 7.64)

0.14

BL baseline, Ca*P calcium–phosphate product, cCa corrected calcium, CI confidence interval, EOT end of treatment, FC ferric citrate hydrate, GASI gastric acid secretion inhibitor, iPTH intact parathyroid hormone, P phosphate, SD standard deviation

^aAnalysis of covariance (covariate, baseline); model: change from baseline = [treatment] [type] [baseline] [treatment] * [type]

^bAdjusted mean difference = [least square mean of FC] − [least square mean of placebo]

^cP value: test for [adjusted mean difference of with GASI] vs [adjusted mean difference of without GASI]