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Table 2 Efficacy parameters

From: Sucroferric oxyhydroxide decreases serum phosphorus level and fibroblast growth factor 23 and improves renal anemia in hemodialysis patients

 

Actual value

Changes

n

mean

SD

n

mean

SD

p-valuem

Serum phosphorus, mg/dL

       

 Baseline

40

7.0

0.7

 Week 8

39

5.5

1.3

39

− 1.5

1.6

< 0.0001

 Week 16

33

5.6

1.5

33

− 1.4

1.8

< 0.0001

Corrected serum calcium, mg/dL

       

 Baseline

40

8.6

0.9

 Week 8

39

8.6

0.8

39

0.0

1.0

0.8459

 Week 16

33

8.7

0.7

33

0.2

0.9

0.3332

Calcium-phosphorus products, mg2/dL2

       

 Baseline

40

59.8

8.4

 Week 8

39

46.8

9.8

39

− 13.1

13.0

< 0.0001

 Week 16

33

48.6

12.4

33

− 11.7

16.4

0.0003

Serum intact-PTHa, pg/mL

       

 Baseline

25

262.3

191.5

 Week 8

19

243.6

193.9

19

− 24.0

108.5

0.3477

 Week 16

22

336.1

589.3

17

− 50.4

137.7

0.1511

FGF23b, pg/mL

       

 Baseline

40

15,282.3

13,548.6

 Week 16

33

10,999.7

10,594.0

33

− 4487.8

12,122.0

0.0412

Hbc, g/dL

       

 Baseline

40

11.1

1.1

    

 Week 8

39

12.6

1.1

39

1.5

1.5

< 0.0001

 Week 16

33

12.7

1.2

33

1.7

1.8

< 0.0001

RBCd, × 10−4/μL

       

 Baseline

40

393.6

40.2

 Week 8

39

419.1

45.7

39

25.5

36.2

< 0.0001

 Week 16

33

410.5

53.0

33

18.8

53.1

0.0500

Hte, %

       

 Baseline

40

34.9

3.1

 Week 8

39

39.3

3.7

39

4.3

4.4

< 0.0001

 Week 16

33

38.8

4.0

33

4.3

5.4

< 0.0001

Cumulative dose of ESAsf, IU

       

 Baselineh

40

24,050.0

18,594.1

 Week 4i

38

24,236.8

20,653.1

38

− 526.3

12,019.1

0.7887

 Week 8j

37

26,533.8

21,679.5

37

1533.8

9123.4

0.3133

 Week 12k

39

15,762.8

15,613.6

39

− 8493.6

14,897.5

0.0010

 Week 16 l

34

14,985.3

15,135.9

34

− 9544.1

20,983.4

0.0122

Cumulative dose of IV-irong, mg

       

 Baselineh

40

20.0

53.6

 Week 4i

38

14.7

38.8

38

− 6.3

41.1

0.3496

 Week 8j

37

3.2

19.7

37

− 18.4

60.1

0.0709

 Week 12k

39

0.0

0.0

39

− 20.5

54.2

0.0233

 Week 16 l

34

10.6

61.7

34

− 8.2

83.4

0.5688

Daily dose of calcium carbonate, g

       

 Baseline

40

1.3

1.2

 Week 4

38

1.3

1.2

38

0.0

0.4

0.5706

 Week 8

39

1.5

1.2

39

0.2

0.6

0.0577

 Week 12

40

1.4

1.2

40

0.1

0.8

0.6348

 Week 16

33

1.4

1.2

33

0.1

0.9

0.3786

Daily dose of sucroferric oxyhydroxide, mg

       

 Baseline

40

1000.0

477.0

 Week 4

38

1256.6

613.7

38

243.4

549.8

0.0097

 Week 8

39

1282.1

626.1

39

269.2

591.6

0.0072

 Week 12

40

1250.0

718.3

40

250.0

662.6

0.0220

 Week 16

34

1323.5

727.0

34

294.1

672.7

0.0156

  1. Cumulative doses of ESAs and intravenous iron were regarded as 0 when they were not administered
  2. aParathyroid hormone
  3. bFibroblast growth factor 23
  4. cHemoglobin
  5. dred blood cell count
  6. eHematocrit
  7. fErythropoiesis-stimulating agents
  8. gIntravenous iron
  9. hWeeks − 4 to 0
  10. iWeeks 0–4
  11. jWeeks 4–8
  12. kWeeks 8–12
  13. lWeeks 12–16
  14. mPaired t-test (vs. baseline)