Sucroferric oxyhydroxide monotherapy for hyperphosphatemia in Indian chronic kidney disease patients undergoing hemodialysis: A phase IV, single-arm, open-label study

Table 1 Demographics and clinical characteristics of the patients at baseline (n = 114), n (%)

Characteristics
Gender
Male	62 (54.39)
Female	52 (45.61)
Age (years)
≥ 65	9 (7.89)
≤ 65	105 (92.11)
Body mass index (kg/m2) (mean ± SD)	22.96 ± 3.37
Asian race	114 (100)
Dialysis history
< 1 year	38 (33.33)
≥ 1 year and < 3 years	39 (34.21)
≥ 3 years	37 (32.46)
Presence of complication
Hypertension	94 (82.46)
Diabetes mellitus	36 (31.57)
Anemia	1 (0.88)
Coronary artery disease	3 (2.63)
Hyperthyroidism	1 (0.88)
Thyroid	1 (0.88)

Table 2 Comparison of serum phosphorus response to baseline phosphorus at each visit (n = 94)

Visit	mean ± SD	P value (compared to baseline)
Serum phosphorus (mg/dL)
Per protocol population (n = 94)
Screening visit: Day 7 to Day 1	7.62 ± 2.02	-
Follow-up visit: Day 28	6.37 ± 2.33	P < 0.05
Follow-up visit: Day 56	5.49 ± 2.19	P < 0.05
End of study visit: Day 84	5.13 ± 1.88	P < 0.05
Change from baseline at Day 28	1.25 ± 1.55	P < 0.05
Change from baseline at Day 56	2.19 ± 2.07	P < 0.05
Change from baseline at Day 84	2.49 ± 2.13	P < 0.05

P value was analysed using Wilcoxon test.

Table 3 Percentage of patients have < 5.5 mg/dL serum phosphorus (n = 94), n (%)

Visit	Percentage
Follow-up visit: Day 28	37 (39.36)
Follow-up visit: Day 56	50 (53.19)
End of study visit: Day 84	62 (65.96)

Table 4 Adverse events possibly or probably related to treatment (n = 114)

Preferred term	Frequency (%)
Diarrhea	3.51
Vomiting	0.88
Total	4.39

Table 5 Laboratory parameters at baseline and end of study (Day 84) (n = 94), n (%)

Parameter	Baseline (mean ± SD)	Day 84 (mean ± SD)	Change from baseline (mean ± SD)	P value (vs baseline)
Serum calcium (mg/dL)	8.87 ± 0.67	8.75 ± 0.90	0.12 ± 0.92	P > 0.05
Serum intact parathyroid hormone (pg/mL)	264.06 ± 196.70	236.89 ± 217.63	27.17 ± 150.89	P > 0.05
Hemoglobin (g/dL)	11.16 ± 2.11	11.36 ± 2.15	-0.21 ± 2.01	P > 0.05
Total red blood cell (million/cu.mm)	3.91 ± 0.92	4.19 ± 0.95	-0.28 ± 0.72	P > 0.05
Total white blood cell (cells/cu.mm)	7057.34 ± 2027.30	7341.11 ± 2010.73	-283.77 ± 2329.78	P > 0.05
Neutrophils	60.03 (10.42)	59.54 (11.38)	0.49 (12.69)	P > 0.05
Lymphocytes	29.35 (10.37)	29.57 (11.31)	-0.21 (10.81)	P > 0.05
Eosinophils	4.92 (3.75)	5.02 (4.14)	-0.10 (5.24)	P > 0.05
Monocytes	4.93 (2.40)	4.77 (3.06)	0.16 (2.92)	P > 0.05
Basophils	0.77 (0.35)	0.79 (0.43)	-0.01 (0.48)	P > 0.05
Platelet (thou/mm³)	2.38 ± 0.77	2.41 ± 0.84	-0.03 ± 0.81	P > 0.05
Hematocrit	34.44 (9.18)	37.58 (22.40)	3.14 (23.27)	P > 0.05
Serum glutamic-oxaloacetic transaminase (U/L)	23.97 ± 15.52	28.29 ± 18.32	-3.85 ± 20.79	P > 0.05
Serum glutamic pyruvic transaminase (U/L)	21.22 ± 14.84	28.21 ± 24.59	-6.98 ± 25.58	P < 0.05
Glucose (mg/dL)	138.38 ± 72.24	124.70 ± 53.52	13.68 ± 63.44	P > 0.05